Glenmark Pharmaceuticals announced today that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi, a topical acne treatment. The drug, which targets patients aged 12 and older, is the first new topical acne treatment with a novel mechanism of action in nearly 40 years.
The shares of Glenmark Pharmaceuticals Limited were trading at ₹1,529 down by ₹11.15 or 0.72 per cent on the NSE today at 12.21 pm.
Winlevi contains clascoterone as its active ingredient, making it the first commercially available topical androgen receptor inhibitor. The treatment can be used in both male and female patients as it has no systemic anti-androgen effects. Two phase 3 studies have shown the effectiveness of clascoterone cream 1 per cent when applied twice daily for 12 weeks.
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The approval stems from a September 2023 agreement where Glenmark in-licensed the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa. This development is particularly significant given that acne vulgaris affects over 90 per cent of the global population at some point in their lives.
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Glenmark, ranked among the Top 100 Companies by R&D and Pharmaceutical Sales according to In Vivo/Scrip 100, will distribute the product in the UK market. The company operates 11 manufacturing facilities across four continents and maintains operations in more than 80 countries.