ZUG, SWITZERLAND -- Galderma 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]