Glenmark Gets EU Nod To Launch Winlevi In 15 Countries

Glenmark Pharmaceuticals Ltd, in collaboration with Cosmo Pharmaceuticals, has announced that the European Commission has granted marketing authorization for Winlevi (clascoterone cream 1%) across 15 European Union countries. This approval paves the way for Glenmark to initiate commercialization of the product in key EU markets.

Winlevi is the first-in-class topical androgen receptor inhibitor approved for the treatment of acne vulgaris in patients aged 12 years and older. It offers a novel mechanism of action by targeting androgen receptors in the skin, a key factor in acne development.

Key highlights from the announcement include:  

• Glenmark will lead the commercial rollout of Winlevi across 15 EU countries, including major markets such as Germany, France, Italy, and Spain.
• The approval follows a successful collaboration with Cosmo Pharmaceuticals, which developed the formulation and holds global rights.
• Winlevi is already approved and marketed in the United States, where it has shown strong clinical efficacy and safety.
• The product is expected to strengthen Glenmark’s dermatology franchise and expand its footprint in the European prescription skincare market.

Sources: Glenmark Pharmaceuticals Press Release, Cosmo Pharmaceuticals Investor Update, European Commission Health Authority.