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Business Wire
24-07-2025
- Business
- Business Wire
Galderma Delivers Record First Half 2025 Net Sales of 2.448 Billion USD and 12.2% Year-on-Year Growth at Constant Currency, Raises Full-Year Top-Line Guidance
ZUG, Switzerland--(BUSINESS WIRE)--Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its financial results for the first half of 2025. Record net sales of 2.448 billion USD, representing net sales growth of 12.2% at constant currency, driven mainly by volume and complemented by favorable mix Double-digit growth in both International markets and the U.S., with strong performance across all product categories, including year-on-year growth of 9.8% for Injectable Aesthetics, 7.7% for Dermatological Skincare, and 26.9% for Therapeutic Dermatology at constant currency Significant progress on the launch of new innovation, including Nemluvio ® (nemolizumab) which continues to outperform, delivering 131 million USD in sales, the ongoing positive uptake of Relfydess™, now launched in 17 markets, and geographic expansion in Fillers & Biostimulators Advancing leadership in science and education, supported by new long-term data on nemolizumab in atopic dermatitis and prurigo nodularis as well as the initiation of new clinical trials in systemic sclerosis and chronic pruritus of unknown origin Growth in Core EBITDA, delivering 555 million USD, up 9.5% year-on-year at constant currency, with a slightly higher than expected Core EBITDA margin for the first half of 22.7% Disciplined capital allocation with continued investments behind organic growth, net leverage reduced to 2.1x, early debt repayment of 110 million USD, debt refinancing of 1.04 billion USD of its term loan, and purchases of treasury shares for a total amount of 323 million USD Raising 2025 full-year guidance on net sales, expecting growth of 12-14% at constant currency (previously 10-12%), and confirming guidance on Core EBITDA margin of approximately 23% at constant currency 'Galderma's strong performance in the first half of 2025 underscores the impact of our executional excellence across product categories and the continued ramp-up of our two potential blockbuster launches, Nemluvio and Relfydess. Reflecting this strong progress and confidence in the business, we are raising our full-year guidance on net sales. With the establishment of our new U.S. headquarters in Miami and sustained scientific momentum, we are also sharpening our focus – accelerating growth and moving from category leadership to becoming a true powerhouse in dermatology.' FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Expand Delivering strong commercial performance Galderma achieved 2.448 billion USD in net sales for the first half of 2025, representing 12.2% year-on-year growth at constant currency. Growth was mainly driven by volume, complemented by favorable mix. This reflects an acceleration in the second quarter, with year-on-year growth of 15.8% at constant currency. The first half saw strong performance across all product categories, including double-digit growth in 7 out of Galderma's top 10 markets. Galderma delivered notable market share gains in Injectable Aesthetics in both geographies (International markets and the U.S.) as well as in Dermatological Skincare in International markets. In Therapeutic Dermatology, Nemluvio maintained its strong momentum with global net sales of 131 million USD. International markets: Galderma sustained its strong momentum with double-digit growth in both Injectable Aesthetics subcategories, as well as in Dermatological Skincare. Injectable Aesthetics saw especially strong growth in Brazil, Canada, China, Mexico, and the U.K., while Dermatological Skincare growth was accelerated by strong performances in China and India. Therapeutic Dermatology's modest growth was mainly driven by Nemluvio sales in Germany. U.S.: The U.S. grew across all product categories in the first half, led by strong performances from Nemluvio and Neuromodulators. In Injectable Aesthetics, Galderma continued to gain share in both Neuromodulators and Fillers & Biostimulators, despite the Fillers market being impacted by market softness and intensified promotional activity. In Dermatological Skincare, Cetaphil made strides in e-commerce as well as with select large retailers, despite continued constrained consumer spending, while Alastin® grew across channels. In Therapeutic Dermatology, Nemluvio's sales ramp-up in prurigo nodularis and atopic dermatitis was higher than expected, more than offsetting the anticipated decline from mature products. Injectable Aesthetics Injectable Aesthetics net sales for the first half of 2025 were 1,240 million USD, with year-on-year growth of 9.8% at constant currency. Neuromodulators achieved net sales of 707 million USD, up 14.7% year-on-year at constant currency. Both the U.S. and International markets reported double-digit growth and continued to gain market share. Dysport ® remains on a strong growth trajectory, while the launch of Relfydess – the first and only ready-to-use liquid neuromodulator created using PEARL™ Technology – continues to deliver ahead of expectations, including some stocking benefits from multiple market launches. As anticipated, growth in the second quarter for Neuromodulators was slightly subdued, following a very strong first quarter with some favorable phasing. Fillers & Biostimulators recorded net sales of 534 million USD, up 3.9% year-on-year at constant currency. With market share gains in the U.S. and International markets, growth was mainly driven by sustained high growth momentum for Sculptra ® as well as the initial uptake of new launches, including Sculptra in China and Restylane ® SHAYPE™ in Brazil. Fillers continued to be impacted by market softness, especially in the U.S., with lower consumer demand and intense promotional activity, while growth in Biostimulators remained very strong, particularly in International markets. Overall, the growth rate for Fillers & Biostimulators in the second quarter was high, following a decline in the previous quarter due to a high comparative base in 2024. Galderma maintained its focus on commercial execution and partnership with healthcare professionals, including an increase in the reach of its education, training and medical awareness activities. These efforts also supported new launches, notably for Relfydess, which is now available in 17 markets, with further global regulatory submissions initiated. Interest and demand for Relfydess have been very high, with positive feedback from early adopters, especially on long duration, fast onset and simple volumetric dosing. Recent Fillers & Biostimulators launches are also performing ahead of expectations. Sculptra continues on its strong launch trajectory in China's fast-growing aesthetics market, while Restylane SHAYPE is outperforming all recent competitive launches in Brazil. Dermatological Skincare Dermatological Skincare net sales for the first half of 2025 were 719 million USD, with year-on-year growth of 7.7% at constant currency. Cetaphil and Alastin, Galderma's flagship Dermatological Skincare brands, continued on their growth trajectories, supported by strong momentum in e-commerce channels globally. Cetaphil growth in International markets remained very strong, with exceptional performance in Asia, where India became a top sales contributor. In the U.S., Cetaphil grew in e-commerce channels and with select large retailers, despite constrained consumer spending. Alastin continued to grow double-digits, with the U.S. performing across channels and steady progress in International market expansion plans. Highlights for the period included the launch of CetaSphere, a new global advocacy network; a major Cetaphil campaign in China with a leading local live streamer leading to rapid sell-through during the '618' shopping festival; and high profile appearances, including a collaboration between Alastin and Halle Berry at the Met Gala and Cannes Film Festival. Additionally, Galderma focused on strong retailer engagement, including Alastin's strategic physician-first approach, targeted execution with local Cetaphil retailers, as well as fast-growing e-commerce channels. Growth was also supported by new innovations such as Cetaphil's Acne Fast Rescue Pimple Patches and Alastin's Restorative Skin Complex with Next Generation TriHex Technology ®. Therapeutic Dermatology Therapeutic Dermatology net sales for the first half of 2025 were 489 million USD, with year-on-year growth of 26.9% at constant currency. This accelerated performance was driven by an impressive ramp-up in Nemluvio sales, notably in the second quarter. This growth more than offset the decline in the category's mature portfolio, especially in the U.S. Nemluvio delivered 131 million USD in net sales, performing ahead of expectations. Sales were primarily driven by the U.S., the majority still from prurigo nodularis, with the contribution from atopic dermatitis quickly increasing. Internationally, Germany's launch trajectory remains strong. Market share gains in both prurigo nodularis and atopic dermatitis in the U.S. were underpinned by increasing underlying demand and market access, spanning more than 70% commercial covered lives as a first-line biologic treatment as of July 16 th, 2025. The commercial uptake was further supported by ongoing sales force expansion, a direct-to-consumer advertising campaign in atopic dermatitis, and deepening engagement with healthcare professionals leveraging recently published long-term data (details below). Global regulatory processes continue to progress, underscoring growing interest and sustained momentum. Nemluvio was approved by the Therapeutic Goods Administration (TGA) in Australia in May 2025 for the treatment of both moderate-to-severe atopic dermatitis and prurigo nodularis. With this decision, Nemluvio is now approved in all selected countries under the Access Consortium framework. In June, Nemluvio was also recommended for routine National Health Service (NHS) funding in England and Wales for moderate-to-severe atopic dermatitis, as outlined in final draft guidance from the National Institute for Health and Care Excellence (NICE). 1 Advancing cutting-edge science and industry-leading medical education Galderma reinforced its leadership in dermatology by presenting several new scientific data and pipeline updates, and by supporting education at key industry events. In June 2025, Galderma presented new long-term data on Nemluvio in both atopic dermatitis and prurigo nodularis as late breaker presentations at the Revolutionizing Atopic Dermatitis (RAD) Conference and the XIV International Congress of Dermatology (ICD), respectively. These new data reinforced Nemluvio's consistent safety profile and durable clinical efficacy on both skin lesions and itch, across both indications, with prolonged treatment up to two years. 2-4 These results build on data from the ARCADIA and OLYMPIA clinical trials – with OLYMPIA being the largest completed pivotal clinical program in prurigo nodularis and the only one assessing long-term safety and efficacy for this condition. 4-6 Also in June, Galderma announced the initiation of two new clinical trials to investigate the efficacy and safety of nemolizumab in treating patients living with systemic sclerosis (SSc) and chronic pruritus of unknown origin (CPUO) – two chronic conditions with high unmet need. 7-9,10 In SSc, Galderma's phase II proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled study investigating nemolizumab in adults. Patient enrolment is planned from the second half of 2025, with completion expected in 2028. In CPUO, Galderma's phase II trial is a randomized, double-blind, placebo-controlled proof-of-concept study exploring the impact of nemolizumab on itch intensity and quality of life in patients without an identifiable underlying cause, with enrollment expected to start in the second half of 2025 in the U.S., and study completion expected in 2026. Overall, nemolizumab is seen as a pipeline within an asset, with the potential to explore additional indications over time as relevant. As the pure-play dermatology category leader, Galderma is spearheading efforts to address the most predominant aesthetic concerns of a new and fast-growing patient population experiencing medication-driven weight loss. In mid-July, Galderma unveiled final nine-month data from a phase IV first-of-its-kind trial showing lasting efficacy and patient satisfaction with Restylane Lyft ® or Contour ® in combination with Sculptra when addressing facial aesthetic changes after medication-driven weight loss. These extended study data reinforce that this treatment regimen can effectively improve facial aesthetic appearance with high patient satisfaction over nine months. Alongside these scientific advancements, Galderma maintained its commitment to market-leading education through a steady flow of regional and local Galderma Aesthetic Injector Network (GAIN) events. Following an earlier memorandum of understanding to work towards a new research and development collaboration, Galderma and L'Oréal signed an agreement for a new research project to use our complementary technologies to develop a non-invasive, ambulatory imaging approach for extracellular matrix remodeling in the skin. Investing in our U.S organization to drive growth Galderma also made important moves to accelerate innovation and growth in the U.S., the company's largest market, with the establishment of its new U.S. headquarters in Miami, Florida. The new site will serve as a strategic hub for Dermatological Skincare and Injectable Aesthetics, reinforcing Galderma's long-term commitment to the market. To support this, Galderma appointed Heather Wallace as President of Galderma U.S., bringing deep experience in dermatology and consumer health. These steps reflect Galderma's continued investment in the market and the potential it sees for the future. Strengthening our financial profile For the first half of 2025, Galderma delivered a record 555 million USD in Core EBITDA, growing 9.5% year-on-year at constant currency in a year of key launches. Core EBITDA margin was 22.7%, with margin erosion slightly better than expected for the period given the strong ramp-up of Nemluvio, despite some reinvestments behind growth. Galderma's underlying profitability, defined as Core EBITDA margin excluding the Core EBITDA impact from nemolizumab, continued to improve. Profitability in the first half of the year benefited from some phasing in research and development. Meanwhile, gross margin was impacted by pricing pressures, especially in the U.S., partially offset by favorable mix. Core net income continued to grow significantly, achieving 329 million USD for the period, driven by strong Core EBITDA growth, lower financing expenses, and a phasing-related improvement of the effective tax rate. Galderma also brought its net leverage down to 2.1x at the end of June 2025. In addition, given strong financial results and confidence in cash generation, Galderma repaid 110 million USD of its debt early, and refinanced 1.04 billion USD of its term loan, including issuing its inaugural Eurobond and new dual tranche CHF bonds following Fitch's investment grade rating. Galderma took steps to further support its shareholder returns with the approval and first payment of a dividend and the repurchase of shares during the accelerated bookbuild offerings which took place in the first half of the year. First, a gross dividend of 0.15 CHF per dividend-bearing share was distributed out of reserves from capital contributions. Second, Galderma repurchased 2.78 million shares for 323 million USD in the context of the accelerated bookbuild offerings of Galderma shares by Sunshine SwissCo GmbH ('EQT'), Abu Dhabi Investment Authority ('ADIA') and Auba Investment Pte. Ltd. ('Auba'), funded from existing liquidity on hand and to be held in treasury to support Galderma's employee participation plans, business development opportunities and/or treasury management. Raising full-year guidance on net sales Reflecting its strong growth trajectory and investments behind significant launches, Galderma is raising its net sales guidance for 2025 to 12-14% year-on-year growth at constant currency, and confirming its Core EBITDA margin, at approximately 23% at constant currency. This guidance update reflects the ramp-up of Nemluvio which is expected to drive significant growth in Therapeutic Dermatology. It also highlights the strong performance in Injectable Aesthetics for the first half of the year. In the second half, Neuromodulators are expected to be impacted by stocking dynamics, notably from the ongoing Relfydess launches and a high comparative base in Latin America. Galderma remains confident in its ability to outgrow the Neuromodulator market globally and expects low 'teens' net sales growth for its Neuromodulators subcategory for the full-year ('teens' defined as numbers greater than 10% and lower than 20%). Fillers & Biostimulators are expected to continue to benefit in the second half from the increasing contribution of new launches and the very strong momentum of Sculptra. Finally, Dermatological Skincare is expected to sustain its growth trajectory globally with expected growth acceleration in the fourth quarter due to seasonal activations. Regarding Core EBITDA margin, while the first half of the year was slightly ahead of expectations given the stronger than anticipated ramp-up of Nemluvio, underlying profitability for the second half of the year is expected to slightly decrease. This reflects the increased seasonal ramp-up of marketing activities for the period and the anticipated impact of U.S. tariffs. Galderma remains confident in its ability to deliver on its guidance considering its manageable exposure to announced U.S. tariffs, which are fully factored-in for the full-year, along with its ability to absorb some further tariff impact and consumer demand-related deterioration. Webcast details Galderma will host a trading update call today at 13:00 CET to discuss the first half 2025 results and respond to questions from financial analysts. Investors and the public may access the webcast by registering on the Galderma Investor Relations website at a recording will also be made available after the event. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Appendices Appendix 1: H1 2025 net sales by product category and geography Appendix 2: Q2 2025 net sales by product category and geography Appendix 3: Reconciliation of H1 2025 P&L from IFRS to Core reporting In million USD IFRS - as reported Exceptional & transformation related items Impairments Amortization Depreciation Core reporting % Net Sales based on Core reporting Net Sales 2,448 - - - - 2,448 Other revenue 18 - - - - 18 Cost of goods sold (761) - 5 105 11 (641) Gross profit 1,705 - 5 105 11 1,826 74.6% Research and development (104) - - - 1 (103) 4.2% Sales and marketing (818) - - - 7 (811) 33.1% General and administrative (276) - 4 17 16 (238) 9.7% Medical and regulatory (55) - - - - (55) 2.2% Distribution (64) - - - 1 (64) 2.6% Other income / (expenses) (29) 29 - - - - - Operating profit as reported 358 Total adjustments 29 9 122 36 Core EBITDA 555 Expand Appendix 4: Reconciliation of H1 2025 of Core EBITDA to IFRS Net Income Appendix 5: Reconciliation of H1 2025 from IFRS Net Income to Core Net Income 12 In million USD H1 2024 H1 2025 Net income / (loss) 47 194 Total EBITDA adjustments 11 59 38 VCB financing revaluation (28) - Amortization 112 122 Foreign exchange loss on financing activities 30 1 Income taxes on above items (10) (25) Core Net Income 12 210 329 Core EPS in USD 13 0.89 1.39 Expand Appendix 6: H1 2025 Total Net Indebtedness In million USD December 31 2024 June 30 2025 Total Indebtedness 14 2,813 2,715 Cash and Cash Equivalents (457) (458) Total Net Indebtedness 2,356 2,257 Expand Appendix 7: Additional modeling metrics Notes and references Note: Due to rounding numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. All ratios, subtotals and variances are calculated using the underlying amount rather than the presented rounded amount. NICE. Nemolizumab for treating atopic dermatitis - technology appraisal guidance. Available online. Accessed June 2025 Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025 Jimenez SA, Mendoza FA, Piera-Velasquez S. A review of recent studies on the pathogenesis of Systemic Sclerosis: focus on fibrosis pathways. Front Immunol. 2025;16: 1551911. doi: 10.3389/fimmu.2025.1551911 Truchetet ME, et al. Current Concepts on the Pathogenesis of Systemic Sclerosis. Clin Rev Allergy Immunol. 2021;64(3): 262–283. doi: 10.1007/s12016-021-08889-8 Teresa J, et al. Therapeutics in chronic pruritus of unknown origin. Itch. 2023;8(1): pe64. doi: 10.1097/itx.0000000000000064 Andrade E, et al. Interventions for chronic pruritus of unknown origin. CDSR. 2020;1(1): CD013128. doi: 10.1002/ H1 2024 adjustments include 48 M USD for IPO related incentive plans, 5 M USD for platform transformation costs, 4 M USD for VCB bonus, 2 M USD for IPO. H1 2025 adjustments include 4 M USD litigation, 6 M USD onerous items, 2 M USD M&A, 9 M USD impairments, 4 M USD restructuring, 13 M USD for operating FX Core Net Income is defined as net income / (loss) from continuing operations adjusted for the same items that are treated as exceptional for purposes of defining Core EBITDA, as well as amortization of intangible assets, foreign exchange gains and losses on financing activities. Taxes on the adjustments between IFRS net income and Core Net Income take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact Core EPS is calculated as Core net income divided by the weighted average number of outstanding shares Indebtedness includes financial debt and lease liabilities Includes assumptions for other income and expenses related to tangible asset impairments, ongoing litigation and onerous items, restructuring charges and others, excluding M&A fees On reported profit before tax Includes interest income and interest expense, excluding FX impact Of reported net income based on prior year results, subject to Board and AGM approval Includes 13 M USD of Operating FX from H1 2025 Forward-looking statements Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "plans", "targets", "aims", " believes", "expects", "anticipates", "intends", "estimates", "will", "may", "continues", "should" and similar expressions. These forward-looking statements reflect, at the time, Galderma's beliefs, intentions and current targets/ aims concerning, among other things, Galderma's results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma's markets, and other factors beyond the control of Galderma). Neither Galderma nor any of their respective shareholders (as applicable), directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof.
Business Upturn
18-06-2025
- Health
- Business Upturn
ICD 2025: New data demonstrate Nemluvio®'s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years
By Business Wire India Published on June 18, 2025, 11:17 IST Zug, Switzerland: An interim analysis of the OLYMPIA long-term extension study to be presented as a late-breaking abstract at the XIV International Congress of Dermatology (ICD) found that Nemluvio was well tolerated and associated with sustained and clinically meaningful improvements in the key signs and symptoms of prurigo nodularis, including both skin lesions and itch, up to two years 1 Results build on data from OLYMPIA – the largest completed pivotal clinical program in prurigo nodularis and the only one assessing long-term safety and efficacy in prurigo nodularis 1-3 This follows the presentation of data from the ARCADIA long-term extension study at the Revolutionizing Atopic Dermatitis (RAD) Conference earlier this month, which showed Nemluvio is well tolerated with sustained and increased improvements in efficacy outcomes in atopic dermatitis patients up to two years4 Galderma (SIX: GALD) today announced data from a new interim analysis of a study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis. The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years.1 These new data will be presented as a late-breaking session at ICD, on Saturday, June 21, 2025 at 08:30 AM CET. This press release features multimedia. View the full release here: 'These promising data go even further in highlighting the extensive benefits of Nemluvio. As this treatment becomes available in more countries around the world, it's highly encouraging to see its robust evidence base continue to expand and strengthen.' BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GLOBAL HEAD OF RESEARCH & DEVELOPMENT GALDERMA Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules, which have a substantial impact on patients' quality of life.5-7 Nemluviois the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31.8,9,10 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation, skin barrier dysfunction, and fibrosis in prurigo nodularis.8-11 It is also the first and only biologic approved for prurigo nodularis as well as atopic dermatitis with four-week dosing intervals from the start of treatment.9,10 The OLYMPIA long-term extension study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and includes 508 patients from the phase II trial or the phase III OLYMPIA 1 and 2 trials.1 Results show that treatment with Nemluvio is associated with sustained and clinically meaningful improvements in symptoms of prurigo nodularis during prolonged treatment up to two years.1 At Week 100 in evaluable patients, the interim analysis shows that: More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale 1 At least 80% achieved 76‑100% healed pruriginous lesions 1 Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator's Global Assessment score1 Nemluvio was well tolerated in the long-term treatment of prurigo nodularis and no new safety signals were identified in this study to date.1 'These impressive results give us even more confidence in the value of nemolizumab – a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets including the EU and U.S., I'm thrilled to be able to see its meaningful impact in the real world.' PROF. SONJA STÄNDER LEAD INVESTIGATOR OF THE OLYMPIA STUDIES IN EUROPE UNIVERSITY HOSPITAL MUNSTER, GERMANY This follows presentation of results from the ARCADIA long-term extension study at the RAD Conference earlier this month, which showed that treatment with Nemluvio was well tolerated and associated with sustained and increased improvements in symptoms of atopic dermatitis during prolonged treatment up to two years.4 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional reviews and submissions are ongoing. Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch in both prurigo nodularis and atopic dermatitis. Separately, the company will share new data from across its Therapeutic Dermatology portfolio in acne, non-melanoma skin cancer, and rosacea. More details on Galderma's scientific presentations at ICD can be found here. About Nemluvio Nemluviowas initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.12,13 About prurigo nodularis Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.5-7 It is an underrecognized and underdiagnosed skin condition, and there are limited studies investigating its prevalence.11,14,15 About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025 Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi: 10.1016/ Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi: 10.1111/jdv.14570 Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed May 2025 Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555-022-00782-2 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: a retrospective database analysis. JAAD Int. 2020;2:28-30. doi: 10.1016/ Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/ View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash Business Wire India, established in 2002, India's premier media distribution company ensures guaranteed media coverage through its network of 30+ cities and top news agencies.
National Post
18-06-2025
- Health
- National Post
ICD 2025: New data demonstrate Nemluvio®'s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years
Article content Sorry, your browser doesn't support embedded videos. Article content An interim analysis of the OLYMPIA long-term extension study to be presented as a late-breaking abstract at the XIV International Congress of Dermatology (ICD) found that Nemluvio was well tolerated and associated with sustained and clinically meaningful improvements in the key signs and symptoms of prurigo nodularis, including both skin lesions and itch, up to two years 1 Results build on data from OLYMPIA – the largest completed pivotal clinical program in prurigo nodularis and the only one assessing long-term safety and efficacy in prurigo nodularis 1-3 This follows the presentation of data from the ARCADIA long-term extension study at the Revolutionizing Atopic Dermatitis (RAD) Conference earlier this month, which showed Nemluvio is well tolerated with sustained and increased improvements in efficacy outcomes in atopic dermatitis patients up to two years 4 Article content Article content ZUG, Switzerland — Galderma (SIX: GALD) today announced data from a new interim analysis of a study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis. The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years. 1 These new data will be presented as a late-breaking session at ICD, on Saturday, June 21, 2025 at 08:30 AM CET. Article content is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules, which have a substantial impact on patients' quality of life. Article content 5-7 Article content Nemluvio Article content Article content is the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31. Article content 8,9,10 Article content IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation, skin barrier dysfunction, and fibrosis in prurigo nodularis. Article content 8-11 Article content It is also the first and only biologic approved for prurigo nodularis as well as atopic dermatitis with four-week dosing intervals from the start of treatment. Article content 9,10 Article content The OLYMPIA long-term extension study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and includes 508 patients from the phase II trial or the phase III OLYMPIA 1 and 2 trials. 1 Results show that treatment with Nemluvio is associated with sustained and clinically meaningful improvements in symptoms of prurigo nodularis during prolonged treatment up to two years. 1 At Week 100 in evaluable patients, the interim analysis shows that: Article content More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale 1 At least 80% achieved 76‑100% healed pruriginous lesions 1 Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator's Global Assessment score 1 Article content Nemluvio was well tolerated in the long-term treatment of prurigo nodularis and no new safety signals were identified in this study to date. 1 'These impressive results give us even more confidence in the value of nemolizumab – a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets including the EU and U.S., I'm thrilled to be able to see its meaningful impact in the real world.' This follows presentation of results from the ARCADIA long-term extension study at the RAD Conference earlier this month, which showed that treatment with Nemluvio was well tolerated and associated with sustained and increased improvements in symptoms of atopic dermatitis during prolonged treatment up to two years. 4 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional reviews and submissions are ongoing. Article content Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch in both prurigo nodularis and atopic dermatitis. Separately, the company will share new data from across its Therapeutic Dermatology portfolio in acne, non-melanoma skin cancer, and rosacea. Article content More details on Galderma's scientific presentations at ICD can be found here. Article content Nemluvio Article content Article content was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga Article content ® Article content and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. Article content 12,13 Article content About prurigo nodularis Article content Prurigo nodularis Article content is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas. Article content 5-7 Article content It is an underrecognized and underdiagnosed skin condition, and there are limited studies investigating its prevalence. Article content 11,14,15 Article content About Galderma Article content Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Article content Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025 Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi: 10.1016/ Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi: 10.1111/jdv.14570 Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed May 2025 Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555-022-00782-2 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: a retrospective database analysis. JAAD Int. 2020;2:28-30. doi: 10.1016/ Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/ Article content Article content Article content Article content Article content Contacts Article content For further information: Article content Christian Marcoux, Chief Communications Officer +41 76 315 26 50 Article content Richard Harbinson Corporate Communications Director +41 76 210 60 62 Article content Céline Buguet Franchises and R&D Communications Director +41 76 249 90 87 Article content Emil Ivanov Head of Strategy, Investor Relations, and ESG +41 21 642 78 12 Article content Article content Article content
Business Wire
18-06-2025
- Health
- Business Wire
ICD 2025: New data demonstrate Nemluvio ® 's (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced data from a new interim analysis of a study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis. The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years. 1 These new data will be presented as a late-breaking session at ICD, on Saturday, June 21, 2025 at 08:30 AM CET. Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules, which have a substantial impact on patients' quality of life. 5-7 Nemluvio is the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31. 8,9,10 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation, skin barrier dysfunction, and fibrosis in prurigo nodularis. 8-11 It is also the first and only biologic approved for prurigo nodularis as well as atopic dermatitis with four-week dosing intervals from the start of treatment. 9,10 The OLYMPIA long-term extension study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and includes 508 patients from the phase II trial or the phase III OLYMPIA 1 and 2 trials. 1 Results show that treatment with Nemluvio is associated with sustained and clinically meaningful improvements in symptoms of prurigo nodularis during prolonged treatment up to two years. 1 At Week 100 in evaluable patients, the interim analysis shows that: More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale 1 At least 80% achieved 76‑100% healed pruriginous lesions 1 Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator's Global Assessment score 1 Nemluvio was well tolerated in the long-term treatment of prurigo nodularis and no new safety signals were identified in this study to date. 1 'These impressive results give us even more confidence in the value of nemolizumab – a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets including the EU and U.S., I'm thrilled to be able to see its meaningful impact in the real world.' PROF. SONJA STÄNDER Expand This follows presentation of results from the ARCADIA long-term extension study at the RAD Conference earlier this month, which showed that treatment with Nemluvio was well tolerated and associated with sustained and increased improvements in symptoms of atopic dermatitis during prolonged treatment up to two years. 4 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional reviews and submissions are ongoing. Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch in both prurigo nodularis and atopic dermatitis. Separately, the company will share new data from across its Therapeutic Dermatology portfolio in acne, non-melanoma skin cancer, and rosacea. More details on Galderma's scientific presentations at ICD can be found here. About Nemluvio Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga ® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. 12,13 About prurigo nodularis Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas. 5-7 It is an underrecognized and underdiagnosed skin condition, and there are limited studies investigating its prevalence. 11,14,15 About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025 Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi: 10.1016/ Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi: 10.1111/jdv.14570 Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed May 2025 Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555-022-00782-2 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: a retrospective database analysis. JAAD Int. 2020;2:28-30. doi: 10.1016/ Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol.
Yahoo
12-06-2025
- Health
- Yahoo
RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years
New interim two-year data from a long-term extension study of Nemluvio in atopic dermatitis reinforce its rapid onset of action and demonstrate its lasting impact across multiple clinical and patient reported outcomes including itch and skin lesions1 Results build on data from the phase III ARCADIA program, showing Nemluvio's consistent safety profile and sustained and increased improvements in efficacy outcomes in atopic dermatitis patients during prolonged treatment up to two years1,2 Two-year data from a long-term extension study of Nemluvio in prurigo nodularis will also be presented later in June at the International Congress of Dermatology ZUG, Switzerland, June 06, 2025--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025. "With Nemluvio now being launched in several countries, it's so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future." BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GLOBAL HEAD OF RESEARCH & DEVELOPMENT GALDERMA Atopic dermatitis affects more than 230 million people worldwide.3 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.9 "The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that."PROFESSOR JONATHAN SILVERBERG LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, PROFESSOR OF DERMATOLOGY, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES, UNITED STATES The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.1 Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.1 At week 104 in evaluable patients, the interim analysis shows that: More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)1 Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch1 Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score1 Patients' quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)1 Results also reinforce Nemluvio's rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.1 Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.1 Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio's rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.11,12 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing. More details on Galderma's scientific presentations at RAD can be found here. About NemluvioNemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.13,14 About atopic dermatitisAtopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.3,15,16 It affects more than 230 million people worldwide.3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.17 Important Safety InformationIndications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used: to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age. to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age. Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you: are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO. are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: Breathing problems or wheezing Swelling of the face, lips, mouth, tongue, or throat Fainting, dizziness, feeling lightheaded Fast pulse Swollen lymph nodes Joint pain Fever Skin rash (red or rough skin) Nausea or vomiting General ill feeling Cramps in your stomach area The most common side effects of NEMLUVIO include: Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches) These are not all of the possible side effects of NEMLUVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. Please see full Prescribing Information including Patient Information. About GaldermaGalderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/ Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390 Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257 View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Richard HarbinsonCorporate Communications +41 76 210 60 62 Céline Buguet Franchises and R&D Communications Director +41 76 249 90 87 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
