Galderma’s Nemluvio® (nemolizumab) approved in UK and Switzerland for atopic dermatitis and prurigo nodularis

Galderma has received significant regulatory approvals for nemolizumab in both the United Kingdom and Switzerland, as announced on February 18, 2025. The United Kingdom's Medicines and Healthcare products Regulatory Agency and Switzerland's Swissmedic have both granted marketing authorization for this new treatment. Nemolizumab is designed to address moderate-to-severe atopic dermatitis and prurigo nodularis, specifically for its subcutaneous application alongside corticosteroids and/or calcineurin inhibitors. This approval is for adults and adolescents aged 12 and above, weighing at least 30 kg, who are candidates for systemic therapy. Nemolizumab is also set for subcutaneous use in treating adults with moderate-to-severe prurigo nodularis.

This milestone marks the first time countries within the Access Consortium framework have approved nemolizumab. The Access Consortium is an international coalition of regulatory authorities that collaborates to tackle mutual challenges. Decisions on nemolizumab in the remaining consortium countries, Australia and Singapore, are anticipated later this year. Nemolizumab has already gained approval in the European Union and the United States for treating both moderate-to-severe atopic dermatitis and prurigo nodularis. Galderma's prominent role in Therapeutic Dermatology is reinforced by these approvals, highlighting its commitment to providing innovative treatments to millions globally.

Atopic dermatitis and prurigo nodularis are severe dermatological conditions affecting large numbers of people: up to 1.6 million in the UK and 18,000 in Switzerland for atopic dermatitis, and 450,000 in Switzerland overall. There is a pressing need for new treatment options to alleviate symptoms such as persistent itching, skin lesions, and poor sleep quality. Itching is particularly distressing, with a substantial percentage of patients seeking relief from it. In fact, 87% of atopic dermatitis patients and 88% of those with prurigo nodularis cite itchiness as their most troublesome symptom.

Dr. Curdin Conrad, Professor of Dermatology at Lausanne University Hospital in Switzerland, expressed enthusiasm about the new approvals, acknowledging the significant impact they could have on patients' quality of life. The introduction of nemolizumab offers patients a novel treatment avenue that targets their most challenging symptoms.

Nemolizumab stands out as the first monoclonal antibody to specifically target the IL-31 receptor alpha, thereby inhibiting IL-31 signaling. IL-31 is a neuroimmune cytokine implicated in causing itching, inflammation, and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis. It is also associated with fibrosis in prurigo nodularis. The approval was informed by comprehensive phase III clinical trials, specifically the ARCADIA and OLYMPIA programs. These trials demonstrated significant improvements in skin lesions, itch, and sleep disturbances for patients with atopic dermatitis and prurigo nodularis. Nemolizumab showed a favorable safety profile consistent with earlier data.

Baldo Scassellati Sforzolini, Galderma's Global Head of R&D, emphasized the importance of nemolizumab's regulatory success as a testament to Galderma's leadership in dermatological innovation. The approvals in the UK and Switzerland are underpinned by strong clinical trial data, underscoring the potential of nemolizumab to address debilitating symptoms in patients with moderate-to-severe forms of these skin conditions.

Galderma, a leader in the dermatology sector, operates in about 90 countries, offering a diverse portfolio of science-driven brands spanning Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Established in 1981, the company is committed to advancing dermatological science and addressing individual skin needs with a focus on improving patient outcomes.