Latest news with #IL-31
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routine funding on the National Health Service in England and Wales for moderate-to-severe atopic dermatitis in final draft guidance from the National Institute for Health and Care Excellence. 1 This follows its recent marketing authorisation by the United Kingdom (UK) Medicines and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
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
