Glenmark, Cosmo secure EU authorization for acne treatment Winlevi

Glenmark Pharmaceuticals Limited and Cosmo Pharmaceuticals N.V. announced that the European Commission has granted Marketing Authorization for Winlevi® (clascoterone 10 mg/g cream). This approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on August 25, 2025.

Winlevi® is authorized for the treatment of acne vulgaris in adults and adolescents aged 12 to less than 18 years, with usage in adolescents limited to facial application. Glenmark will initiate commercialization across 15 EU countries, including Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

This approval represents Glenmark’s first new chemical entity launch in Europe, strengthening its presence in the dermatology sector. Giovanni Di Napoli, chief executive of Cosmo, highlighted the collaboration's strength and Winlevi's role as a first-in-class topical innovation for acne treatment.