Dermatology specialist Galderma (SWX:GALD) announced on Friday that it has received European Commission approval for Nemluvio to treat moderate-to-severe atopic dermatitis in patients aged 12 years and older and moderate-to-severe prurigo nodularis in adults.

The monoclonal antibody is the first to specifically target IL-31 receptor alpha, addressing inflammation, skin barrier dysfunction and fibrosis associated with these conditions.

Approval in the European Union is based on results from the phase III ARCADIA and OLYMPIA trials, which demonstrated significant improvements in itch, skin lesions and sleep disturbance. Nemluvio showed statistically significant skin clearance at Week 16 in ARCADIA trials and rapid itch reduction in prurigo nodularis within four weeks in OLYMPIA trials.

The treatment is the first biologic approved for both conditions with four-week dosing intervals from initiation. Nemluvio was well tolerated across trials, with a safety profile consistent with prior data.

Already approved by the US Food and Drug Administration, Nemluvio is under review in multiple markets, including Canada, Brazil and South Korea. Galderma expects peak sales to exceed USD2bn, with a blockbuster sales run-rate anticipated by the end of 2027.