Cosmo Pharmaceuticals receives regulatory approval by the European Commission for Winlevi® in the EU, following on the positive CHMP opinion

· Cosmo Pharmaceuticals NV

Cosmo Pharmaceuticals N.V., a global leader in AI-powered healthcare and specialty pharma, today announced that the European Commission has granted regulatory approval in the EU for Winlevi® (clascoterone 1% cream) for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. This formal approval came following on the positive recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 25th of August 2025. Cosmo is already working at full speed with its commercial partners to prepare for launch across 20 European markets.

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