Business
Cosmo and Glenmark Announce Market Authorisation of Winlevi® (clascoterone) 10 mg/g cream for Treatment of Acne in 17 countries in Europe
Cosmo Pharmaceuticals N.V. (SIX: COPN) ("Cosmo") and Glenmark Pharmaceuticals Limited (Glenmark), 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.
About this update from Glenmark Pharmaceuticals Limited
[{"type":"text","content":"DUBLIN and MUMBAI, India, Dec. 1, 2025 /PRNewswire/ -- Cosmo Pharmaceuticals N.V. (SIX: COPN) ("Cosmo") and Glenmark Pharmaceuticals Limited (Glenmark), 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.","length":446,"tagName":"p"},{"type":"image","alt":"Glenmark Logo","displaySize":"","headline":null,"caption":"Glenmark Logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":248,"url":"https://media.zenfs.com/en/prnewswire.com/665b8e82087cbb982ffe3ea107634a26"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/QQPQSICzWHjx5eGgMRHVrQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQzNztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/665b8e82087cbb982ffe3ea107634a26","width":400,"height":248}}},{"type":"text","content":"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 17 countries in EU namely Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.","length":465,"tagName":"p"},{"type":"text","content":"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."","length":374,"tagName":"p"},{"type":"text","content":"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 u...