Cosmo Receives Positive CHMP Opinion for Winlevi® for Treatment of Acne in Adults and Adolescents, Following Successful Re-examination

· Cosmo Pharmaceuticals NV

Cosmo Pharmaceuticals N.V., 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.

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