Galderma’s Nemluvio (Nemolizumab) Granted Marketing Authorization in the United Kingdom and Switzerland for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis

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--(BUSINESS WIRE)--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