Ireland-based life sciences company Cosmo Pharmaceuticals NV (SIX:COPN) and Glenmark Pharmaceuticals Limited (BSE:532296) (NSE:GLENMARK), an India-based pharmaceutical company, announced on Monday that they have received marketing authorisation from the European Commission for Winlevi (clascoterone 10 mg/g cream).

This follows the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in August 2025.

Winlevi is authorised 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.

Glenmark will now start to commercialise Winlevi across 17 countries in the EU: Belgium, Bulgaria, Czechia, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

Giovanni Di Napoli, Cosmo CEO, 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."