Glenmark and Cosmo Secure EU Approval for Acne Treatment Winlevi
Filing Summary
Glenmark Pharmaceuticals Ltd and Cosmo Pharmaceuticals N.V. have received Marketing Authorization from the European Commission for Winlevi (clascoterone) 10 mg/g cream, targeting acne vulgaris treatment in 15 European countries. This approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Glenmark will commercialize Winlevi in countries including France, Spain, and Sweden. The authorization allows usage in adults and adolescents aged 12 to under 18, with adolescent application limited to the face. This marks Glenmark’s first New Chemical Entity launch in Europe.
Glenmark Pharmaceuticals Ltd and Cosmo Pharmaceuticals N.V. have announced that the European Commission has granted Marketing Authorization for Winlevi (clascoterone) 10 mg/g cream. This authorization is for the treatment of acne vulgaris in both adults and adolescents aged 12 to under 18 years, with usage in adolescents limited to facial application. The approval follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use on August 25, 2025. Glenmark will commence the commercialization of Winlevi across 15 European countries, including Bulgaria, France, and Sweden.
The filing does not disclose specific financial terms or payment structures related to the commercialization of Winlevi. There is no mention of revenue projections or financial commitments associated with this authorization. The document focuses on the regulatory approval and the subsequent steps for market entry in the specified European countries.
The scope of the authorization includes the treatment of acne vulgaris, a common dermatological condition. The cream is designed for topical application, with specific guidelines for adolescent use restricted to facial areas. The filing emphasizes the regulatory compliance achieved through this authorization, enabling Glenmark to distribute the product in the European market. The document does not provide technical specifications or detailed descriptions of the product’s formulation beyond the concentration of clascoterone.
The market context provided in the filing highlights Glenmark’s strategic move to expand its dermatology portfolio in Europe. This authorization represents Glenmark’s first New Chemical Entity launch in the region, aligning with its objective to enhance its presence in the dermatology sector. The filing does not elaborate on the competitive landscape or market demand for acne treatments in Europe.
The timeline for the commercialization of Winlevi is set to begin following the receipt of the Marketing Authorization. Glenmark plans to initiate the product launch across the 15 specified countries, although specific dates for market entry are not detailed in the filing. The document confirms the involvement of both Glenmark and Cosmo in the regulatory and commercialization processes.
Cosmo Pharmaceuticals N.V. is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing. The company designs and manufactures advanced solutions addressing critical medical needs. Cosmo collaborates with global pharmaceutical and MedTech companies to enhance healthcare delivery.
Glenmark Pharmaceuticals Ltd is a research-led global pharmaceutical company with operations in over 80 countries. The company focuses on branded, generics, and OTC segments, with therapeutic areas including respiratory, dermatology, and oncology. Glenmark aims to strengthen its dermatology presence in Europe through strategic product launches and regulatory compliance.