Cosmo Pharmaceuticals N.V. has secured a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending European approval of Winlevi® (clascoterone 1% cream) for treating facial acne vulgaris in both adults and adolescents aged 12 to <18 years. The decision follows a successful re-examination of an initial negative CHMP opinion issued in April 2025.
Regulatory Breakthrough After Initial Setback
The CHMP initially concluded that the benefit-risk balance of Winlevi® was negative for therapeutic use in adolescents while considering the product approvable in adults. Following this initial refusal, Cosmo initiated a formal re-examination procedure, providing a deeper clinical assessment supported by leading dermatology experts and an expert Professor of endocrinology. The procedure included consultation with an Ad-Hoc Expert Group comprising dermatologists and endocrinologists.
The CHMP has now concluded that the benefit-risk profile of Winlevi® is favorable for both adults and adolescents, recommending approval in both age groups, with usage in adolescents limited to facial application.
First-in-Class Mechanism of Action
Winlevi® acts by inhibiting androgen receptors in the skin, reducing sebum production and inflammation—two key drivers of acne pathogenesis. Its novel mechanism of action, combined with minimal systemic absorption, makes it a compelling treatment option for both physicians and patients.
"This is a real breakthrough," said Prof. Brigitte Dréno, founder member of the European Association of Dermato-Oncology, past president of the French Society of Dermatology, and member of the American Academy of Dermatology. "We've been waiting for an innovation like this – a topical anti-androgen that is well-tolerated, effective, and safe for adolescents. It will be a valuable addition to our treatment options."
Addressing Unmet Medical Need
The adolescent population represents a large proportion of acne patients in Europe, and until now, had no access to a topical anti-androgen solution. The positive CHMP opinion significantly expands Winlevi®'s addressable market 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.
Commercial Preparation Underway
Cosmo is working with its commercial partners to prepare for launch across 20 European markets. "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."
The positive CHMP opinion is expected to materially contribute to Cosmo's mid- and long-term growth trajectory, marking a significant expansion of Winlevi®'s European indication and unlocking a significant growth opportunity across Europe.
