Dermatology company Galderma (SIX: GALD) announced on Friday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending the approval of nemolizumab for treating moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union. If approved, nemolizumab would be the first monoclonal antibody in the EU targeting IL-31 receptor alpha, a neuroimmune cytokine central to itch, inflammation, and skin barrier dysfunction.

Nemolizumab, administered subcutaneously every four weeks, is recommended for patients aged 12 and older with atopic dermatitis and adults with prurigo nodularis, both requiring systemic therapy. The decision follows its US FDA approval in August 2024 for prurigo nodularis treatment.

The recommendation is based on phase III trials, including the ARCADIA and OLYMPIA programs. ARCADIA trials demonstrated significant improvement in itch and skin lesions in over 1,700 patients with moderate-to-severe atopic dermatitis within 16 weeks, with itch relief as early as Week 1. OLYMPIA trials, the largest conducted for prurigo nodularis, showed rapid reductions in itch and skin nodules in over 500 patients, with notable improvements by Week 4.

Nemolizumab was well-tolerated across trials, and its safety profile aligns with earlier data. Pending approval from the European Commission, the treatment will address significant unmet needs for patients with these chronic and debilitating conditions.

Galderma operates in approximately 90 countries It acquired the worldwide rights for nemolizumab (excluding Japan and Taiwan) from Chugai Pharmaceutical in 2016. The company continues to advance innovative solutions in dermatology to improve patient outcomes.