10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, randomised, placebo controlled Phase 3 clinical trials enrolling >1,400 patients with acne vulgaris.

Cosmo Pharmaceuticals is delighted to announce a pivotal step forward in its mission. Cosmo has officially submitted the marketing authorisation application for its innovative acne treatment clascoterone 1% cream (Winlevi) to the EMA through the centralised procedure, aimed at obtaining a single marketing authorisation for the product in the European Union.

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