UK Approves Glenmark’s novel acne winlevi

Glenmark Pharmaceuticals today announced that it has approved Winlevi, a topical acne treatment, to the market from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Targeting patients age 12 and older, the drug is the first new topical acne treatment in nearly 40 years with a new mechanism of action.

Shares of Glenmark Pharmaceuticals Limited fell by £1,529 or 0.72% on the NSE at 12:21pm today.

Winlevi contains clascoterone as its active ingredient, making it the first commercially available local androgen receptor inhibitor. Treatment can be used in both male and female patients because it does not have a systemic antiandrogen effect. Two phase 3 studies have shown that when the effectiveness of clascoterone cream is applied twice a day, 1% of cases apply for 12 weeks.

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The approval comes from a September 2023 agreement in which Glenmark attempts to administer COSMO Pharmaceuticals products for distribution in Europe and South Africa. This development is especially important given that vulgaris interrogation affects more than 90% of the world’s population at some point in life.

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According to In vivo/Script 100, Glenmark, ranked among the top 100 companies by R&D and pharmaceutical sales, distributes its products in the UK market. The company operates 11 manufacturing facilities on four continents and maintains operations in more than 80 countries.