Cosmo Secures Favorable CHMP Recommendation for Winlevi(R) as Acne Treatment for Adults and Teens After Successful Re-Evaluation

Approval of Winlevi®: The European Medicines Agency's CHMP has recommended approval of Winlevi® (clascoterone 1% cream) for treating facial acne vulgaris in adults and adolescents aged 12 to <18 years, following a successful re-examination of an earlier negative opinion.

Significance for Cosmo Pharmaceuticals: This recommendation represents a strategic milestone for Cosmo Pharmaceuticals, allowing them to introduce a first-in-class topical anti-androgen therapy to the European market, which is expected to enhance their growth opportunities.

Clinical Assessment and Expert Consultation: After an initial refusal, Cosmo provided additional clinical data and consulted with dermatology and endocrinology experts, leading to a favorable benefit-risk assessment for both age groups, with specific usage guidelines for adolescents.

Market Preparation: Cosmo is actively preparing for the launch of Winlevi® across 20 European markets, emphasizing their commitment to delivering impactful healthcare solutions for patients and shareholders.