Glenmark Pharma gets EC nod for acne drug Winlevi in 15 European countries

Glenmark Pharmaceuticals has received marketing authorization from the European Commission (EC) for Winlevi (clascoterone 10 mg/g cream), a novel topical treatment for acne, across 15 European countries.

The approval resulted from a collaboration between Glenmark and Cosmo Pharmaceuticals N.V.

The approval covers the treatment of acne vulgaris in adults and adolescents aged 12 to under 18 years, with usage in adolescents restricted to facial application. Glenmark will commercialize the product across 15 European countries: Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

Christoph Stoller, President & Business Head Europe and Emerging Markets of Glenmark Pharmaceuticals, said, The approval is a key milestone in executing our mission to become a research-led, global pharmaceutical company. Winlevi is the first NCE launch of Glenmark in Europe and is key to strengthening our presence in dermatology in the region. We are committed to executing successful launches with urgency and precision, ensuring timely access for patients in full alignment with regulatory and access frameworks.

Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.

Glenmark Pharmaceuticals, the company, reported a 72.3% jump in consolidated net profit to Rs 610.25 crore on a 76.6% increase in revenue from operations to Rs 6,003.79 crore in Q2 FY25.

Shares of Glenmark Pharmaceuticals fell 1.12% to Rs 1,844.65 on the BSE.

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