IL-31RA

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. The UK regulator has specifically approved the drug to treat atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents aged 12 years and older with a body weight of at least 30kg and for adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy. Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 1.6 million people in the UK, while prurigo nodularis, which causes intense itch and thick skin nodules, affects approximately 18,000 people in the UK. Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions. Nemluvio, which was initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction. The MHRA’s decision comes shortly after the European Commission authorised Nemluvio for both conditions and makes the drug the first approved monoclonal antibody in the UK that specifically targets interleukin-31 receptor alpha. The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. Baldo Scassellati Sforzolini, global head of research and development at Galderma, said: “[Nemluvio’s] approval in the UK… was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programmes, which show that [it] has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.”

The European Commission (EC) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. The drug has been authorised for use in atopic dermatitis patients aged 12 years and older, and adults with prurigo nodularis. Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy. Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 40 million people in the EU, with up to 66% of adults experiencing moderate-to-severe forms of the condition. Meanwhile, prurigo nodularis, which causes intense itch and thick skin nodules, is estimated to affect up to 111 people per 100,000 in the EU depending on the country. Despite available treatments, Galderma said there is a need for new options to effectively relieve the signs and symptoms of both conditions. Initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, Nemluvio is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction. The EC’s decision comes two months after the European Medicines Agency’s human medicines committee recommended Nemluvio for both indications and makes the drug the first approved monoclonal antibody that specifically targets interleukin-31 receptor alpha. The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one. The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four. Lead investigator of the ARCADIA studies in Europe, Diamant Thaçi, University of Lubeck, said: “Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms… 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.”

These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review processes ongoing in the remaining countries – Australia and Singapore Nemolizumab, which is also approved in the EU and U.S., is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31 – a neuroimmune cytokine that drives itch and other symptoms in both moderate-to-severe atopic dermatitis and prurigo nodularis1-6 Zug, Switzerland – February 18, 2025 – Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumab’s subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, 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.7,8 These are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges. Decisions in the remaining countries within the Access Consortium, Australia and Singapore, are expected later this year. Nemolizumab is also approved in the European Union and United States for both moderate-to-severe atopic dermatitis and prurigo nodularis.5,6 Galderma’s leadership in Therapeutic Dermatology is evidenced by the recent regulatory approvals of nemolizumab, and its ongoing commitment to bringing this novel treatment to millions of patients around the world. Atopic dermatitis and prurigo nodularis are debilitating skin conditions that affect up to 1.6 million and 18,000 people in the UK, respectively, and 450,000 people altogether in Switzerland.9-14 There is a need for new treatment options for these diseases to effectively relieve the signs and symptoms such as persistent itch, skin lesions and poor sleep quality.1,2,15-17 Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis saying that they are seeking freedom from itch, and 88% of patients with prurigo nodularis rating itch as their worst symptom.18,19 “These approvals offer patients with moderate-to-severe atopic dermatitis and prurigo nodularis a much-needed novel treatment option, given the potential burden and negative impact on quality of life associated with these conditions. I am looking forward to offering my patients this new treatment option which has the potential to address their most troublesome symptoms.” DR. CURDIN CONRAD PROFESSOR OF DERMATOLOGY LAUSANNE UNIVERSITY HOSPITAL, SWITZERLAND Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3 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 in fibrosis in prurigo nodularis.1-4 This approval is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs, which demonstrated that nemolizumab clinically improved skin lesions, itch, and sleep disturbance in atopic dermatitis and prurigo nodularis, respectively.20-22 Nemolizumab was well tolerated in both clinical trial programs, and its safety profile was generally consistent with earlier data, and between trials.3,20-22 “Nemolizumab’s continued regulatory success underscores Galderma’s strong leadership in Therapeutic Dermatology, and our commitment to bringing innovative treatments to the patients. Its approval in the UK and Switzerland was driven yet again by robust data from the ARCADIA and OLYMPIA clinical trial programs, which show that nemolizumab has the potential to improve some of the most debilitating symptoms of both moderate-to-severe atopic dermatitis and prurigo nodularis.” BALDO SCASSELLATI SFORZOLINI, M.D., PH.D. GLOBAL HEAD OF R&D 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: www.galderma.com. For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43