Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals announced that the European Commission (EC) has granted Marketing Authorization (MA) for Winlevi® (clascoterone 10 mg/g cream), following the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on 25 August 2025.
Winlevi® is authorized in EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. With receipt of this approval, Glenmark will initiate commercializing Winlevi® across 15 countries in EU namely Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden.