Glenmark Pharmaceuticals and Cosmo Pharmaceuticals N.V. announced that the European Commission (EC) has granted Marketing Authorization (MA) for Winlevi® (clascoterone 10 mg/g cream) for the treatment of acne in 15 European countries. The authorization is for both adults and adolescents aged 12 to <18 years, with limitations for facial application in adolescents. Glenmark will initiate commercialization across these countries.
European Market Authorization
Glenmark Pharmaceuticals and Cosmo Pharmaceuticals N.V. announced that the European Commission (EC) granted Marketing Authorization (MA) for Winlevi® (clascoterone 10 mg/g cream). The approval follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on August 25, 2025.
Treatment Details
Winlevi® is now authorized for the treatment of acne vulgaris in adults and adolescents aged 12 to <18 years. Usage in adolescents is limited to facial application. Glenmark plans to commercialize Winlevi® across 15 EU countries. These include Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.
Executive Perspectives
Giovanni Di Napoli, Chief Executive Officer of Cosmo, stated this approval shows their commitment to advancing dermatologic care. They’re excited to make this first-in-class topical innovation available to patients across Europe.
Christoph Stoller, President & Business Head – Europe and Emerging Markets at Glenmark Pharmaceuticals, sees the approval as a milestone in their mission to become a research-led, global pharmaceutical company. Launching Winlevi will strengthen their presence in Dermatology in the region.
Source: BSE