Latest news with #prurigoNodularis
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
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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
Yahoo
26-05-2025
- Health
- Yahoo
Prurigo Nodularis Market - Global and Regional Analysis and Forecasts 2025-2035
The global prurigo nodularis market is surging due to rising prevalence, increased awareness, and treatment innovations. Key drivers include advanced biologic therapies like dupilumab, addressing quality of life impacts and patient well-being. Major pharmaceutical players like Sanofi and Regeneron lead market expansion. Increasing demand for accessible, effective treatments highlights growth opportunities, particularly in underserved regions. Dublin, May 26, 2025 (GLOBE NEWSWIRE) -- The "Prurigo Nodularis Market - A Global and Regional Analysis: Focus on Country and Regional Analysis - Analysis and Forecast, 2025-2035" report has been added to global prurigo nodularis market is witnessing significant growth due to the increasing prevalence of prurigo nodularis, rising awareness among patients and healthcare professionals about prurigo nodularis, advancement in treatment options, and technological innovation. Prurigo nodularis, characterized by intensely itchy, raised nodules on the skin, significantly affects the quality of life for those suffering from this chronic skin condition. The market offers a wide range of treatment solutions, including biologic therapies, topical treatments, oral medications, and phototherapy, all aimed at providing effective management of PN symptoms and improving patient healthcare systems worldwide evolve to provide better care for individuals suffering from severe atopic dermatitis (AD), the global severe atopic dermatitis market is becoming increasingly essential. This market is expanding as both healthcare providers and consumers seek reliable, high-quality solutions to manage severe AD more effectively. The demand for these treatments is being fueled by the growing awareness of the importance of early intervention, comprehensive care, and the need to manage the physical, psychological, and social well-being of individuals living with severe of the key drivers of the global prurigo nodularis market is the rising incidence of the condition, particularly among patients with underlying skin disorders like atopic dermatitis and eczema. As more individuals are diagnosed with prurigo nodularis, particularly in aging populations and those with chronic skin conditions, the demand for effective treatment options is growing. Environmental factors, such as air pollution and changing lifestyles, are also contributing to the development and worsening of prurigo nodularis. Additionally, the growing recognition of the long-term effects of prurigo nodularis on patients' quality of life including social isolation, emotional distress, and physical discomfort is driving demand for effective management significant strides have been made in the development of biologic therapies and systemic medications aimed at treating prurigo nodularis. The approval of biologic treatments such as dupilumab (Dupixent) and other targeted immune-modulating agents has revolutionized the management of prurigo nodularis. These treatments offer improved efficacy and fewer side effects compared to traditional therapies, making them a popular choice for patients with moderate-to-severe forms of the condition. Innovations in both systemic and topical treatments are fueling market growth by expanding the range of available treatment the market's positive growth trajectory, several challenges continue to impact the global prurigo nodularis market. One of the major challenges facing the prurigo nodularis market is the high cost of biologic treatments, which can limit access for patients, especially in lower-income regions. While these advanced therapies are more effective and carry fewer side effects, their high price points make them inaccessible to many individuals. This challenge is particularly pronounced in developing countries, where healthcare infrastructure may be less advancements in biologic therapies are improving the management of Prurigo nodularis, there remains a significant gap in the availability of targeted, effective treatments for all patients. Many existing therapies are either too general or not entirely effective in addressing the underlying causes of the condition, leaving a need for further innovation in treatment options. Also, the complexity of some treatment regimens, particularly biologics and oral medications, can affect patient adherence. Regular injections, oral medications, and ongoing therapies can be difficult for some patients to manage long-term, leading to challenges in ensuring consistent treatment and symptom is a significant opportunity in the R&D of novel therapies for prurigo nodularis. Pharmaceutical companies are investing in the development of new biologics, monoclonal antibodies, and immune-modulating agents that target the underlying causes of PN, offering more specialized treatment options for patients. Moreover, as healthcare access improves in emerging regions such as Asia-Pacific and the rest of the World, the demand for advanced treatments for prurigo nodularis is expected to increase. These regions are witnessing growing patient populations and a rising need for specialized care, providing opportunities for market expansion and the introduction of innovative global prurigo nodularis market is highly competitive, with major pharmaceutical players and emerging biotech companies developing and commercializing therapies for the condition. Companies such as Sanofi S.A., Regeneron Pharmaceuticals, AbbVie, and Eli Lilly and Company are leading the way with biologic treatments like Dupixent and Rinvoq, as well as oral medications and topical solutions. There is also a growing presence of smaller biotech firms developing innovative therapies, particularly in the biologic and immune-modulating players are focusing on expanding their portfolios, improving treatment efficacy, and increasing accessibility, particularly in emerging markets. Many companies are also exploring novel treatment options, such as monoclonal antibodies and combination therapies, to better address the complexities of prurigo Topics Covered:1. Global Prurigo Nodularis Market: Market Outlook1.1 Introduction1.2 Market Trends1.3 Regulatory Framework1.4 Pricing Analysis1.5 Market Dynamics2. Global Prurigo Nodularis Market (Region), ($Million), 2023-20352.1 North America2.2 Europe2.3 Asia Pacific2.4 Rest of the World3. Global Prurigo Nodularis Market: Competitive Landscape and Company Profile3.1 Key Strategies and Development3.1.1 Mergers and Acquisitions3.1.2 Synergistic Activities3.1.3 Business Expansions and Funding3.1.4 Product Launches and Approvals3.1.5 Other Activities3.2 Company Profiles Galderma Sanofi S.A. Trevi Therapeutics AbbVie Regeneron Pharmaceuticals Eli Lilly and Company Merck & Co., Inc. Incyte Corporation Celgene Corporation For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error 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
