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Cosmo Receives Positive CHMP Opinion for Winlevi(R) for Treatment of Acne in Adults and Adolescents, Following Successful Re-Examination
Dublin, Ireland--(Newsfile Corp. - August 27, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending European approval of Winlevi® (clascoterone 1% cream) for the treatment of facial acne vulgaris in both adults and adolescents aged 12 to <18 years. The decision follows a...
About this update from Cosmo Pharmaceuticals Nv
[{"type":"text","content":"Dublin, Ireland--(Newsfile Corp. - August 27, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending European approval of Winlevi® (clascoterone 1% cream) for the treatment of facial acne vulgaris in both adults and adolescents aged 12 to <18 years. The decision follows a successful re‑examination of the initial negative CHMP opinion issued in April.","length":569,"tagName":"p"},{"type":"text","content":"This recommendation for approval marks a significant expansion of Winlevi®’s European indication and positions Cosmo to deliver a first-in-class topical anti-androgen therapy to the largest acne treatment segment in the region. Winlevi® is already approved in the United States, Canada, the United Kingdom, Australia, Malaysia, Singapore and Jordan markets.","length":357,"tagName":"p"},{"type":"text","content":"“The recommendation for approval by CHMP is a major strategic milestone for Cosmo,” said Giovanni Di Napoli, CEO of Cosmo. “It reflects the strength of our science, the quality of our engagement with regulators, and our deep commitment to advancing care in dermatology. Most importantly, it brings a breakthrough therapy to millions of adolescents and adults suffering from acne. This outcome is fully aligned with our Vision 2030 and unlocks a significant growth opportunity across Europe.”","length":491,"tagName":"p"},{"type":"text","content":"In its previous review, the CHMP concluded that the benefit–risk balance of Winlevi® was negative for therapeutic use in adolescents (12 to <18 years of age), while considering the product approvable in adults; it recommended refusing marketing authorization for the indication Cosmo had applied for, namely the treatment of acne vulgaris in patients 12 years of age and older.","length":380,"tagName":"p"},{"type":"text","content":"Following the initial CHMP refusal, Cosmo initiated a formal re-examination procedure and provided a deeper clinical assessment supported by leading dermatology experts and an expert Professor of endocrinology. The procedure also included the consultation of an Ad-Hoc Expert Group comprising dermatologists and endocrinologists. The CHMP has now co...