Cosmo Pharmaceuticals N.V. (COPN.SW) announced that the European Commission has granted regulatory approval for Winlevi (clascoterone 1% cream) in the European Union. The topical treatment is now authorized for use in managing acne vulgaris in both adults and adolescents aged 12 to under 18 years, with adolescent usage restricted to facial application.
This milestone follows a positive recommendation issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on August 25, 2025. The endorsement paved the way for formal approval, marking a significant step forward in expanding access to innovative dermatological therapies across Europe.
Cosmo Pharmaceuticals is actively collaborating with its commercial partners to prepare for the product's launch in 20 European markets. The company is moving swiftly to ensure timely availability and distribution of Winlevi.
Acne vulgaris is among the most common skin conditions worldwide, affecting over 90 percent of people at some point in their lives and often leading to both physical and emotional consequences, including reduced self-esteem and quality of life.
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