Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals announced a major regulatory milestone with the European Commission granting Marketing Authorisation for Winlevi® (clascoterone 10 mg/g cream). The approval follows a positive recommendation from the European Medicines Agency’s CHMP earlier this year and paves the way for the product’s rollout across 15 European nations.

Winlevi®, a first-in-class topical therapy, is now authorised for the treatment of acne vulgaris in adults and adolescents aged 12 to under 18 years, with paediatric use restricted to facial application. As part of the approval, Glenmark will begin commercialising the product in Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden.

Cosmo is a life sciences company developing solutions in MedTech AI, dermatology, gastrointestinal care, and CDMO services. With operations spanning Ireland, the U.S., and Italy, Cosmo focuses on elevating standards of care through innovation at the intersection of technology and medical science. Giovanni Di Napoli, CEO of Cosmo Pharmaceuticals, highlighted the strategic significance of the approval, noting that the partnership with Glenmark has resulted in bringing a novel dermatology innovation to the European market. “Winlevi represents a breakthrough in topical acne treatment, and this authorisation ensures greater access for patients across the region,” he said.

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Glenmark is a global, research-driven pharmaceutical company with a strong presence in branded, generics, and OTC segments. The company operates 11 manufacturing facilities across four continents and serves patients in over 80 countries. It has been recognised among the top biopharmaceutical and generics players globally and is one of the few Indian pharmaceutical companies with SBTi-approved greenhouse gas reduction targets.

Christoph Stoller, President & Business Head – Europe and Emerging Markets at Glenmark Pharmaceuticals, emphasised that the authorisation marks Glenmark’s first new chemical entity (NCE) launch in Europe. “This achievement strengthens our dermatology portfolio and aligns with our long-term commitment to bring science-led innovations to global markets. We are prepared to execute a structured launch to ensure timely and compliant patient access,” he added.

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