Latest news with #Nemluvio
Business Wire
4 days ago
- Health
- Business Wire
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
ZUG, Switzerland--(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. BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GALDERMA Expand 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 Expand 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 itch 1 Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score 1 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 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. 13,14 About atopic dermatitis Atopic 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 Information Indications: 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 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 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)
Yahoo
4 days ago
- 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
04-04-2025
- Health
- Globe and Mail
Celgene Crp., Novartis, Pfizer, Galderma, Genentech, Incyte Crp., Trevi Therapeutics, Vyne Therapeutics
The Key Prurigo Nodularis Companies in the market include - Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others. DelveInsight's 'Prurigo Nodularis Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Prurigo Nodularis, historical and forecasted epidemiology as well as the Prurigo Nodularis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. Some of the key facts of the Prurigo Nodularis Market Report: The Prurigo Nodularis market size is anticipated to grow with a significant CAGR during the study period (2020-2034) In March 2025, Incyte (Nasdaq: INCY) announced findings from its pivotal Phase 3 TRuE-PN clinical trial program, including the TRuE-PN1 and TRuE-PN2 studies, assessing the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients (18 years and older) with prurigo nodularis (PN). In March 2025, Incyte (Nasdaq: INCY) announced positive topline results from its pivotal Phase 3 STOP-HS trial assessing the safety and efficacy of povorcitinib (INCB054707), an oral JAK1 inhibitor, in adults (≥18 years) with moderate to severe hidradenitis suppurativa (HS). Povorcitinib, a selective JAK1 inhibitor, is also being investigated in Phase 3 trials for vitiligo and prurigo nodularis (PN) and in Phase 2 trials for asthma and chronic spontaneous urticaria (CSU). In February 2025, Galderma (SWX:GALD) announced that the European Commission has granted approval for Nemluvio in the EU to treat both moderate-to-severe atopic dermatitis and prurigo nodularis. Nemluvio is now authorized for subcutaneous use in patients aged 12 and older with moderate-to-severe atopic dermatitis requiring systemic therapy, as well as in adults with moderate-to-severe prurigo nodularis eligible for systemic treatment. According to Morgan et al. (2022), the estimated prevalence of prurigo nodularis was recorded at 3.27 cases per 10,000 patients. In 2023, among the 7MM, the United States had the largest diagnosed prevalent population of prurigo nodularis. As per estimates, in Europe, the highest prevalence of age-specific cases of prurigo nodularis was observed in the 40-59 years age group, representing over 30% of the total cases in 2023. DUPIXENT (dupilumab) stands as the sole therapeutic approved by the US FDA for the treatment of prurigo nodularis, with several other treatments currently undergoing development. Key Prurigo Nodularis Companies: Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others Key Prurigo Nodularis Therapies: Nalbuphine ER, Nemolizumab, Vixarelimab(KPL-716), Povorcitinib(INCB-54707), Ruxolitinib Cream, INCB054707, serlopitant, CC-10004, Pimecrolimus, Abrocitinib, Dupilumab SAR231893, and others The Prurigo Nodularis epidemiology based on gender analyzed that females are affected more as compared to males, in the case of Prurigo Nodularis The Prurigo Nodularis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Prurigo Nodularis pipeline products will significantly revolutionize the Prurigo Nodularis market dynamics. Prurigo Nodularis Overview Prurigo nodularis is a chronic skin condition characterized by the development of intensely itchy nodules or bumps on the skin. These nodules can vary in size and color and often appear on the arms, legs, or trunk. The itching associated with prurigo nodularis can be severe and persistent, leading to scratching and potentially causing further irritation and skin damage. The exact cause of prurigo nodularis is not fully understood, but it is believed to involve a combination of factors such as underlying skin conditions, nerve dysfunction, and immune system abnormalities. Get a Free sample for the Prurigo Nodularis Market Report Prurigo Nodularis Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Prurigo Nodularis Epidemiology Segmentation: The Prurigo Nodularis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Download the report to understand which factors are driving Prurigo Nodularis epidemiology trends @ Prurigo Nodularis Epidemiology Forecast Prurigo Nodularis Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Prurigo Nodularis market or expected to get launched during the study period. The analysis covers Prurigo Nodularis market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Prurigo Nodularis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Prurigo Nodularis Therapies and Key Companies Discover more about therapies set to grab major Prurigo Nodularis market share @ Prurigo Nodularis Treatment Market Prurigo Nodularis Market Strengths Novel drug formulations are unlocking the new market outlook and the potential to improve the QoL of patients suffering from the serious symptoms associated with chronic neurologically mediated conditions for which there are few, if any, treatment options. Vixarelimab's dual mechanism offers potential pruritus relief and nodule improvement in prurigo nodularis. Prurigo Nodularis Market Opportunities Increasing population gives a lucrative opportunity to increase the awareness and innovation of therapeutics to drive the prurigo nodularis market. Due to one approved drug in the market, there is a huge opportunity for the companies who are coming with novel emerging therapies. Scope of the Prurigo Nodularis Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Prurigo Nodularis Companies: Trevi Therapeutics, Galderma, Genentech, Incyte Corporation, Vyne Therapeutics Inc., Celgene Corporation, Novartis, Pfizer, Regeneron Pharma, and others Key Prurigo Nodularis Therapies: Nalbuphine ER, Nemolizumab, Vixarelimab(KPL-716), Povorcitinib(INCB-54707), Ruxolitinib Cream, INCB054707, serlopitant, CC-10004, Pimecrolimus, Abrocitinib, Dupilumab SAR231893, and others Prurigo Nodularis Therapeutic Assessment: Prurigo Nodularis current marketed and Prurigo Nodularis emerging therapies Prurigo Nodularis Market Dynamics: Prurigo Nodularis market drivers and Prurigo Nodularis market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Prurigo Nodularis Unmet Needs, KOL's views, Analyst's views, Prurigo Nodularis Market Access and Reimbursement Table of Contents 1. Prurigo Nodularis Market Report Introduction 2. Executive Summary for Prurigo Nodularis 3. SWOT analysis of Prurigo Nodularis 4. Prurigo Nodularis Patient Share (%) Overview at a Glance 5. Prurigo Nodularis Market Overview at a Glance 6. Prurigo Nodularis Disease Background and Overview 7. Prurigo Nodularis Epidemiology and Patient Population 8. Country-Specific Patient Population of Prurigo Nodularis 9. Prurigo Nodularis Current Treatment and Medical Practices 10. Prurigo Nodularis Unmet Needs 11. Prurigo Nodularis Emerging Therapies 12. Prurigo Nodularis Market Outlook 13. Country-Wise Prurigo Nodularis Market Analysis (2020–2034) 14. Prurigo Nodularis Market Access and Reimbursement of Therapies 15. Prurigo Nodularis Market Drivers 16. Prurigo Nodularis Market Barriers 17. Prurigo Nodularis Appendix 18. Prurigo Nodularis Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Yahoo
03-03-2025
- Business
- Yahoo
AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum
New data on Nemluvio® (nemolizumab), including an oral e-poster presentation characterizing the impact of Nemluvio in different pruriginous lesion types in prurigo nodularis from the phase III OLYMPIA program, and post-hoc analyses exploring the continuous response of Nemluvio up to 56 weeks in atopic dermatitis patients from the ARCADIA 1&2 trials and long-term extension study who had partial or no disease response at week 16 The latest data from the phase III READY-4 and phase IIIb RELAX studies of ready-to-use liquid neuromodulator Relfydess® (RelabotulinumtoxinA), which has previously demonstrated a six-month clinical effect and rapid onset from day one for frown lines and crow's feet, in the phase III READY clinical trial program1-3 Updates on Restylane® and Sculptra®, including data from a study exploring the benefits of Restylane Lyft™ or Contour™ with Sculptra in patients with medication-driven weight loss with associated facial volume loss, as well as new data from Galderma's acne and sensitive skin product portfolio With 22 presentations in total, the extent and range of data to be shared underscore the pace of Galderma's growth journey, which AAD attendees can further explore at booth #2021 ZUG, Switzerland, March 03, 2025--(BUSINESS WIRE)--Galderma will present updates from across its broad dermatology portfolio at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place from March 7-11, 2025 in Orlando, Florida. The company will present 22 e-posters – including two oral presentations – with updates on a number of its innovative products, including Nemluvio, Sculptra, Restylane and Relfydess. These presentations combined reinforce the strength of Galderma's growth journey, its status as the pure-play category leader in dermatology, and its innovative pipeline. "We're bringing impactful new science to this year's AAD meeting, with new data on Nemluvio – our treatment for prurigo nodularis and atopic dermatitis – and the latest from our Dermatological Skincare and Injectable Aesthetics portfolios. This demonstrates how Galderma continues to move from strength to strength, as a category leader in dermatology with a strong portfolio spanning the full spectrum of this fast-growing market." BALDO SCASSELLATI SFORZOLINI, M.D., HEAD OF R&DGALDERMA New data on atopic dermatitis and prurigo nodularis New data on Nemluvio reinforce its benefit for a broad range of patients with prurigo nodularis and atopic dermatitis. An oral presentation will report new data on the efficacy of Nemluvio treatment up to Week 16 across different pruriginous lesion types in patients with prurigo nodularis from the phase III OLYMPIA program. This will be presented on Friday, March 7. The company will also share data demonstrating the continuous response with Nemluvio up to 56 weeks in patients with moderate-to-severe atopic dermatitis who had a partial or no response to treatment at Week 16 in the ARCADIA 1&2 trials and long-term extension study. Alongside this, real-world evidence on atopic dermatitis will be shared, including an oral e-poster presentation with findings from a retrospective analysis of access disparities for atopic dermatitis patients across ethnic groups using the U.S. Medicaid database (Sunday, March 9), and data exploring the association between itch severity and initiation of biologic therapy. On Sunday, March 9, Galderma will also host an Industry Session Theatre titled 'Targeting the IL-31 Neuroimmune Pathway: Transforming Itch and Inflammation Outcomes'. Presented by Dr. Jonathan Silverberg and Dr. Sarina Elmariah, this patient and expert panel discussion will delve into the crucial need to address neuroimmune interactions with atopic dermatitis and prurigo nodularis, the impact of IL-31, and how a targeted treatment improves real patient outcomes. Aesthetic advancements across Galderma's portfolio Galderma will also present the latest data from across its Injectable Aesthetics portfolio, including updates on Restylane, Sculptra, and Relfydess. Interim data from a study exploring the benefits of Restylane Lyft or Contour with Sculptra in patients with medication-driven weight loss with associated facial volume loss will be shared. Results from a comparative study evaluating the synergistic effects for midface improvement when pairing Sculptra with a skincare regimen will also be presented, as well as a comparative analysis of suggested genetic pathways affected by Sculptra vs another biostimulator, and consensus and evidence-based recommendations on the impact of minimally invasive treatments on subsequent facial surgery for additional aesthetic enhancement. Additional data from Galderma's Restylane portfolio includes the first ever ultrasound comparison of the tissue integration, dynamic support, and lifting capacity of Restylane Contour versus another rheologically different hyaluronic acid filler. Data from an AI-enabled Manufacturer and User Facility Device Experience database analysis of delayed complications with hyaluronic acid fillers will also reveal technology-based differences. Finally, data from the phase III READY-4 study, designed to evaluate the safety of Relfydess for the long-term treatment of moderate-to-severe frown lines and crow's feet, as well as from the phase IIIb RELAX study, evaluating the long-lasting efficacy and satisfaction of Relfydess in adults with moderate-to-severe frown lines over a 12-month period, will be presented. A separate subgroup analysis of pooled phase III data will explore the benefits of Relfydess treatment for frown lines and crow's feet of different baseline severity. These presentations build on previously announced data from the READY clinical trial program, which demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow's feet when treated with Relfydess.1-3 Updates on innovative solutions for acne and sensitive skin Galderma will also present updates on its product portfolio for sensitive skin, including a dermal patch for acne-prone skin, a Ceramide Serum and Vitamin C Serum, and a novel cream designed to improve the appearance of aging skin. In acne, results of a worldwide profiling survey on the association between adult acne and sensitive skin will be shared. Presentations on Galderma's CTMP™: Cleanse, Treat, Moisturize, Protect regimen will also reveal its impact on adherence, treatment outcomes, patient satisfaction, and overall skin quality in patients with acne and sensitive skin. More details on Galderma's scientific presentations at AAD can be found here. About Nemluvio (Nemolizumab)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 and Taiwan. 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.4,5 Nemluvio has been approved by the European Commission for both moderate-to-severe atopic dermatitis and moderate-to-severe prurigo nodularis in the European Union (EU).6 It is now approved in the EU for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.6 The U.S. FDA has also approved Nemluvio for the treatment of adults with prurigo nodularis and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.7 Nemluvio is also under review for the treatment of both diseases by several additional regulatory authorities around the world. Further submissions to regulatory authorities in additional countries are ongoing. About Relfydess (RelabotulinumtoxinA)Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.8-10 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.1-3,8-10 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.8-10 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. RelabotulinumtoxinA is an investigational drug product in the U.S. Following the completion of the European Decentralized Procedure resulting in a positive decision for the use of Relfydess, Galderma has received national approvals in 14 European countries, as well as a marketing authorization from Australia's Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the United Kingdom. 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 Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthet Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131 Ablon G, et al. Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study. Dermatol Surg. 2024. doi: 10.1097/DSS.0000000000004470 Relfydess. EU Summary of Product Characteristics 2024 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed February 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed February 2025 Nemluvio. EU Summary of Product Characteristics 2025 NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024 Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - RelabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin View source version on Contacts Christian Marcoux, Communications +41 76 315 26 50 Sébastien CrosCorporate Communications +41 79 529 59 85 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Sign in to access your portfolio
Yahoo
14-02-2025
- Health
- Yahoo
Galderma's Nemluvio® (Nemolizumab) Approved in the European Union for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis
Ad hoc announcement pursuant to Art. 53 LR This approval from the European Commission is based on robust results from the phase III OLYMPIA and ARCADIA clinical trial programs, showing that Nemluvio has the potential to address the significant unmet needs of patients with atopic dermatitis and prurigo nodularis1-3 There is a need for new treatment options for atopic dermatitis and prurigo nodularis to effectively relieve the signs and symptoms such as persistent itch, skin lesions and poor sleep quality4-8 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis5,8-10 Nemluvio is the first monoclonal antibody in Galderma's portfolio of innovative, science-based products, which span the full spectrum of the fast-growing dermatology market ZUG, Switzerland, February 14, 2025--(BUSINESS WIRE)--Galderma (SWX:GALD) today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.11 "Throughout Galderma's four decades in dermatology we have consistently worked to meet the needs of patients and deliver first-in-class treatment options. This has been exemplified through the clinical and regulatory success achieved with our unique monoclonal antibody, Nemluvio. As the first biologic treatment in our Therapeutic Dermatology portfolio, Nemluvio shows our commitment to advancing dermatology by expanding into new areas of need."FLEMMING ØRNSKOV, M.D., MPHCHIEF EXECUTIVE OFFICERGALDERMA Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis.5,8-10 It is also the first and only biologic approved for atopic dermatitis and prurigo nodularis with four-week dosing intervals from the start of treatment.11 This approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, in which Nemluvio significantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively.1-3 Results from the ARCADIA 1 and ARCADIA 2 trials demonstrated that patients treated with Nemluvio, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), showed statistically significant improvements on skin clearance in both co-primary endpoints at Week 16, when compared to placebo +TCS/TCI.1 The trials also met all key secondary endpoints, confirming significant responses on itch as early as Week 1 and statistically significant improvements in sleep disturbance.1 Both co-primary endpoints were also met in the OLYMPIA 1 and OLYMPIA 2 clinical trials, where Nemluvio monotherapy demonstrated significant and clinically meaningful improvements on itch and skin lesions at Week 16, when compared to placebo.2,3 The trials met all key secondary endpoints, showing rapid reduction in itch due to prurigo nodularis and sleep disturbance within four weeks of treatment initiation.2,3 Nemluvio was well tolerated in all trials, and its safety profile was generally consistent with earlier data, and between trials.1-3 "Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms, including chronic itch, skin lesions, poor sleep quality and mental health conditions. With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly, and effectively ease the key symptoms of these diseases and therefore the burden on patients' lives."PROFESSOR DIAMANT THAÇILEAD INVESTIGATOR OF THE ARCADIA STUDIES IN EUROPEUNIVERSITY OF LUBECK, GERMANY "Nemolizumab's benefits have been demonstrated in its comprehensive clinical trial programs in both atopic dermatitis and prurigo nodularis, including the OLYMPIA 1 and 2 studies, which make up the largest completed pivotal program in prurigo nodularis to date. These clinical data, plus its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic solution for dermatologists to support their patients."PROF. SONJA STÄNDERLEAD INVESTIGATOR OF THE OLYMPIA STUDIES IN EUROPEUNIVERSITY HOSPITAL MÜNSTER, GERMANY Nemluvio is also approved by the U.S. Food and Drug Administration for the treatment of atopic dermatitis and prurigo nodularis.12 It is under review for the treatment of both diseases by several additional regulatory authorities around the world, including Canada, Brazil, and South Korea, and via the Access Consortium framework in countries such as Australia, Singapore and Switzerland. Further submissions to other regulatory authorities are ongoing. As previously communicated, peak sales of Nemluvio are expected to reach more than 2 billion USD (expected beyond the 2023-2027 mid-term guidance period). Galderma anticipates Nemluvio to approach 'blockbuster' net sales run-rate by the end of 2027. Media can find more information about atopic dermatitis and prurigo nodularis 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 and Taiwan. 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 the ARCADIA clinical trial program1,15,16 The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2. These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors). The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator's global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks. About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.5,17,18 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.5,19 It affects approximately 10 to 40 million people in the European Union, with up to 66% of adults suffering with a moderate-to-severe form of the condition.20,21 While currently available treatments may improve some signs and symptoms of the disease, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree.5-8 About the OLYMPIA clinical trial program2,3,22,23 The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively. 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.24-26 It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.27,28 The majority of patients report that the persistent itch negatively impacts their quality of life.29 Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.30,31 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 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 Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333 Ständer S, et al. Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: A Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;160. doi: 10.1001/jamadermatol.2024.4796 Chisolm SS. A Review of the Current Management and Burden of Prurigo Nodularis in the United States. AJMC. 2023; 2023;29(suppl 5):S63-S72. 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 Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi:10.3390/biomedicines10112927 Katoh N, Ohya Y, Ikeda M, et al. Clinical practice guidelines for the management of atopic dermatitis 2018. J Dermatol. 2019;46(12):1053-1101. doi:10.1111/1346-8138.15090 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. 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/ 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 Nemluvio. EU Summary of Product Characteristics 2025 NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024 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 February 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 February 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed February 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed February 2025 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257 Luger, T, et al. Clinical and Humanistic Burden of Atopic Dermatitis in Europe: Analyses of the National Health and Wellness Survey. Dermatol Ther (Heidelb). 2022;12:949–969. Oisín S, et al. 545 - Prevalence of moderate and severe atopic dermatitis in Ireland: a cross-sectional, real-world study of a secondary care population. BJD. 2024;190(S2):ii43–ii44. An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (NCT04501679). Available online. Accessed February 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed February 2025 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 Ryczek A, et al. Prevalence of Prurigo Nodularis in Poland. Acta Derm Venereol. 2020;100:adv00155. doi: 10.2340/00015555-3518 Ständer, S, et al. Epidemiology of Prurigo Nodularis compared with Psoriasis in Germany: A Claims Database Analysis. Acta Dermato-Venereologica. 2020;100(18):1–6. Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol. 2020;100(8):adv00119. doi:10.2340/00015555-3471 Joel MZ, et al. Risk of itch-induced sleep deprivation and subsequent mental health comorbidities in patients with prurigo nodularis: A population-level analysis using the Health Improvement Network. E-poster presented at EADV 2023. Abstract available online Kwatra SG. Breaking the itch–scratch cycle in prurigo nodularis. N Engl J Med. 2020;382(8):757-758. doi:10.1056/NEJMe1916733 View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Sébastien CrosCorporate Communications +41 79 529 59 85 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Sign in to access your portfolio
