Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

Cosmo Pharmaceuticals 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 August 25, 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.

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented, "This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatologic care. Winlevi represents a first-in-class topical innovation that redefines how acne is treated, and we are excited to see it become accessible to patients throughout Europe."

Christoph Stoller, President & Business Head - Europe and Emerging Markets, Glenmark Pharmaceuticals, said, "The approval is a key milestone in executing our mission to become a research-led, global pharmaceutical company. Winlevi is the first NCE launch of Glenmark in Europe and is key to strengthening our presence in Dermatology in the region. We are committed to executing successful launches with urgency and precision, ensuring timely access for patients in full alignment with regulatory and access frameworks."