Cosmo, Glenmark secure EU approval for acne drug Winlevi; to launch in 15 countries

Cosmo Pharmaceuticals and India’s Glenmark Pharmaceuticals said on Tuesday the European Commission has granted marketing authorisation for Winlevi (clascoterone 10 mg/g cream), clearing the way for its commercial launch across 15 European countries.The approval follows a positive opinion from the European Medicines Agency’s drug advisory panel in August. Winlevi is cleared for the treatment of acne vulgaris in adults and in adolescents aged 12 to under 18, with its use in younger patients restricted to facial application.

Glenmark said it will begin rolling out the drug in Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden.

Cosmo CEO Giovanni Di Napoli said the decision underscored the companies’ collaboration and marked a “first-in-class topical innovation” in acne treatment. Christoph Stoller, who heads Glenmark’s European and emerging markets business, called the approval a major milestone and the company’s first new chemical entity launch in Europe.Glenmark, which operates across branded, generics and OTC segments with a focus on dermatology, respiratory and oncology, has manufacturing facilities on four continents and a presence in more than 80 countries.

Shares of Glenmark Pharma were trading 1.1% lower at a price of ₹1,844.30 on the BSE.

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