Latest news with #Nemolizumab
Business Wire
2 days ago
- Health
- Business Wire
Galderma's Nemluvio ® (nemolizumab) Receives National Institute for Health and Care Excellence (NICE) Recommendation for Moderate-to-severe Atopic Dermatitis in England and Wales
LONDON--(BUSINESS WIRE)--Galderma today announced that nemolizumab has been recommended for routine funding on the National Health Service in England and Wales for moderate-to-severe atopic dermatitis in final draft guidance from the National Institute for Health and Care Excellence. 1 This follows its recent marketing authorisation by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years and older with a body weight of at least 30 kg, who are candidates for systemic therapy. 2 'Additional advances are needed in the treatment of atopic dermatitis due to the heterogeneity of the disease. Nemolizumab addresses this need for treatments with a favourable safety profile that effectively target both itch and skin lesions – two of the most burdensome symptoms of this disease – and we are delighted that patients in England and Wales will now have access to it.' GALDERMA Expand Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31. 2 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis. 5,9,10 It is also the first and only biologic approved for atopic dermatitis with four-week dosing intervals from the start of treatment. 2 After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose of nemolizumab is 30 mg every eight weeks. 2 The approval was based on results from the phase III ARCADIA clinical trial program. The phase III ARCADIA 1 and ARCADIA 2 trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), clinically improved skin lesions, and rapidly and significantly improved itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis, when compared to placebo +TCS/TCI. 3 Significant itch relief was observed as early as Week 1. 3 Nemolizumab was generally well tolerated in all trials. 3,10 It does not require preliminary laboratory evaluations or monitoring during treatment. 2 'It is hugely positive to have a new treatment option available for atopic dermatitis patients that can help to ease the relentless and unforgiving burden this disease can have on their lives. Nemolizumab will be an important addition to the current treatment landscape with its novel mode of action and infrequent dosing regime.' DR ANDREW PINK CONSULTANT DERMATOLOGIST GUY'S AND ST THOMAS' NHS FOUNDATION TRUST LONDON, UNITED KINGDOM Expand Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease which affects approximately 1.6 million people in the UK. 4-8 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. Atopic dermatitis can also be associated with several comorbid conditions, namely mental health disorders and other autoimmune- or immune-mediated diseases. 11-14 Given the significant burden of these symptoms and the heterogeneity of the disease, there is a need for additional treatment options with a favourable safety profile that effectively target both itch and skin lesions. 5,11,15 'Relentless itch makes life so difficult for the many people living with moderate-to-severe atopic eczema (atopic dermatitis) in the UK. It disrupts sleep and impacts people's ability to concentrate throughout the day. This is in addition to the painful physical symptoms of inflamed, sore, cracked and bleeding skin. National Eczema Society welcomes the NICE decision to recommend nemolizumab for treating moderate-to-severe atopic dermatitis. It's really important we have a range of treatment options, so patients have the chance of accessing a treatment that works effectively for them.' ANDREW PROCTOR Expand About nemolizumab Nemolizumab 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 paediatric, adolescent, and adult patients. 16,17 About the ARCADIA clinical trial program 18,19 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, multicentre, 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 (12 years and over) and adult patients 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. 4-6 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis. 5,20 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 NICE. Nemolizumab for treating atopic dermatitis - technology appraisal guidance. Available online. Accessed June 2025 Nemolizumab. UK summary of product characteristics 2025. Available online. Accessed June 2025 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 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: 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 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi: 10.1056/NEJMra2023911 Kleyn E, et al. Prevalence and treatment patterns of adult atopic dermatitis in the UK Clinical Practice Research Datalink. Skin Health and Disease. 2023;3(4):e232. doi:10.1002/ski2.232 UK Office for National Statistics - national population projections: 2021-based interim. Available online. Accessed June 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. 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/ 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 Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi: 10.3390/biomedicines10112927 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 June 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 June 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed June 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed June 2025 Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257
Globe and Mail
11-03-2025
- Health
- Globe and Mail
Chronic Pruritus Market Set for Significant Expansion by 2034, Predicts DelveInsight
The Chronic Pruritus Market is making significant strides, fueled by innovative treatment approaches and ongoing research advancements. DelveInsight's latest 7MM report delivers deep insights into key epidemiology trends and evolving market dynamics, shaping the future of chronic pruritus management. DelveInsight's 'Chronic Pruritus - Market Insight, Epidemiology, And Market Forecast - 2034″ report offers an in-depth understanding of the Chronic Pruritus, historical and forecasted epidemiology as well as the Chronic Pruritus market trends in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan. Some of the key facts of the Chronic Pruritus Market Report: • According to DelveInsight, the market for Chronic Pruritus in the 7MM is expected to witness notable growth during the study period from 2020 to 2034. • The 12-month cumulative incidence of chronic pruritus in the general population may be as high as ~7%. • KORSUVA (difelikefalin) is the first FDA-approved treatment for Chronic Kidney Disease-Associated Pruritus (CKD-aP). • Other treatments for chronic pruritus include topical and systemic corticosteroids, antihistamines, immunomodulators, phototherapy, and other off-label medications. • In Dec 2024, Galderma received U.S. FDA approval for Nemluvio® (Nemolizumab) for patients with moderate-to-severe atopic dermatitis. • In Aug 2024, Galderma received U.S. FDA approval for Nemluvio® (Nemolizumab) for adult patients living with prurigo nodularis. • In May 2024, Clexio reached the 50% enrollment milestone in the CLE-400 Phase II proof-of-concept study for subjects suffering from chronic pruritus associated with Notalgia Paresthetica. • Emerging drugs in the chronic pruritus pipeline include Dupixent, CLE-400, and others. • Key players in the chronic pruritus market include Sanofi, Keymed Biosciences, Bellus Health, Clexio Biosciences, and others. To Know in detail about the Chronic Pruritus market outlook, drug uptake, treatment scenario, and epidemiology trends, Click here: Chronic Pruritus Market Forecast Chronic Pruritus Overview Chronic pruritus (persistent itching) is a distressing condition lasting for more than six weeks, often associated with dermatological, neurological, systemic, or psychogenic disorders. Common causes include eczema, psoriasis, chronic kidney disease, diabetes, and nerve disorders. The persistent itch significantly impacts quality of life, leading to sleep disturbances, anxiety, and depression. Management depends on the underlying cause and may involve antihistamines, corticosteroids, immunomodulators, or targeted biologics. Get a Free sample for the Chronic Pruritus Market Report: Chronic Pruritus 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. Chronic Pruritus Epidemiology Segmentation: The Chronic Pruritus epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by: • Prevalence-specific cases of chronic pruritus • Disease-specific cases of chronic pruritus Download the report to understand which factors are driving Chronic Pruritus epidemiology trends @ Chronic Pruritus Epidemiology Forecast Chronic Pruritus Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Chronic Pruritus market or expected to be launched during the study period. The analysis covers the market uptake of chronic pruritus 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 Chronic Pruritus 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 collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Chronic Pruritus Market Strengths • New insights into the neurological pathways of chronic itch are driving novel treatment developments. • The growing recognition of chronic pruritus as a serious condition fuels demand for effective therapies. Chronic Pruritus Market Weaknesses • Many current treatments provide only symptomatic relief without addressing the root cause. • Patients with refractory pruritus often struggle to find effective and long-term solutions. Scope of the Chronic Pruritus Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] • Key Chronic Pruritus Therapies: Dupixent, CLE-400, and others. • Key Chronic Pruritus Companies: Sanofi, Keymed Biosciences, Bellus Health, Clexio Biosciences, and others. • Chronic Pruritus Therapeutic Assessment: Chronic Pruritus currently marketed and Chronic Pruritus emerging therapies • Chronic Pruritus Market Dynamics: Chronic Pruritus market drivers and Chronic Pruritus market barriers • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies • Chronic Pruritus Unmet Needs, KOL's views, Analyst's views, Chronic Pruritus Market Access and Reimbursement To learn more about the key players and advancements in the Chronic Pruritus Treatment Landscape, visit the Chronic Pruritus Market Analysis Report Table of Contents 1. Chronic Pruritus Market Report Introduction 2. Executive Summary for Chronic Pruritus 3. SWOT analysis of Chronic Pruritus 4. Chronic Pruritus Patient Share (%) Overview at a Glance 5. Chronic Pruritus Market Overview at a Glance 6. Chronic Pruritus Disease Background and Overview 7. Chronic Pruritus Epidemiology and Patient Population 8. Country-Specific Patient Population of Chronic Pruritus 9. Chronic Pruritus Current Treatment and Medical Practices 10. Chronic Pruritus Unmet Needs 11. Chronic Pruritus Emerging Therapies 12. Chronic Pruritus Market Outlook 13. Country-Wise Chronic Pruritus Market Analysis (2020–2034) 14. Chronic Pruritus Market Access and Reimbursement of Therapies 15. Chronic Pruritus Market Drivers 16. Chronic Pruritus Market Barriers 17. Chronic Pruritus Appendix 18. Chronic Pruritus 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 business growth and overcome challenges with a practical approach. Media Contact Company Name:DelveInsight Contact Person: Jatin Vimal Email:Send Email Phone: +14699457679 Address:304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website: Press Release Distributed by To view the original version on ABNewswire visit: Chronic Pruritus Market Set for Significant Expansion by 2034, Predicts DelveInsight
