Nemolizumab Receives EU Approval for Atopic Dermatitis and Prurigo Nodularis

Galderma has secured European Commission approval for Nemluvio (nemolizumab), a first-in-class monoclonal antibody designed to treat moderate-to-severe atopic dermatitis (AD) and prurigo nodularis (PN). This milestone, based on findings from the phase III ARCADIA and OLYMPIA clinical trial programs, marks a significant advancement in dermatology by addressing the persistent itch, skin lesions, and sleep disturbances associated with these conditions.

Nemolizumab is the first biologic therapy that directly targets IL-31 receptor alpha, inhibiting the IL-31 signaling pathway—a key driver of itch, inflammation, and skin barrier dysfunction in both diseases. Unlike other biologics, nemolizumab is the only approved treatment for AD and PN with 4-week dosing intervals from initiation.

The approval follows compelling data from the ARCADIA trials, which demonstrated that nemolizumab, in combination with topical corticosteroids or calcineurin inhibitors, led to significant skin clearance and itch relief as early as week 1. The OLYMPIA trials further confirmed its efficacy, with rapid improvements in itch and skin lesions among patients with PN within 4 weeks. The therapy was well tolerated across all studies, with a safety profile consistent with previous data.

With this approval, nemolizumab provides a long-awaited treatment option for millions of European patients struggling with these chronic, debilitating skin diseases. Already approved by the US Food and Drug Administration, the drug is now under regulatory review in multiple countries, including Canada, Brazil, and South Korea.

Reference
Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate-to-severe atopic dermatitis and prurigo nodularis. Press release. Galderma. February 14, 2025. Accessed February 18, 2025. https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-approved-european-union-moderate-severe-atopic-dermatitis-and