Glenmark Pharmaceuticals and Cosmo Pharmaceuticals N.V. have announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winlevi®, a breakthrough topical treatment for acne vulgaris in patients aged 12 and older.
Winlevi® is the first topical acne treatment in nearly 40 years with a novel mechanism of action. Its active ingredient, clascoterone, is the first topical androgen receptor inhibitor, effectively reducing sebum production without systemic anti-androgen effects. This makes it a safe and effective treatment option for both males and females.
Clinical trials have demonstrated that clascoterone cream, 1%, applied twice daily for 12 weeks, significantly reduces inflammatory and non-inflammatory acne lesions compared to a placebo. The treatment was also well tolerated, making it a promising solution for individuals struggling with acne.
Under a 2023 licensing agreement, Glenmark has secured the rights to distribute Winlevi® across Europe and South Africa, reinforcing its commitment to dermatology innovations. Acne vulgaris affects over 90% of people at some point in their lives, often leading to physical discomfort and emotional distress.
Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals, said, “We are excited to receive the approval and bring Winlevi® to the UK market, offering patients a new and efficacious treatment for acne. This approval by the MHRA represents a significant step forward in our mission to enhance dermatology care. Our partnership with Cosmo Pharmaceuticals plays an important role in enabling us to expand our dermatology portfolio, and we are proud to offer this new treatment to market that can improve the quality of life for those living with acne.”
With Winlevi®’s approval, patients in the UK now have access to an innovative, first-in-class treatment that offers effective acne management with minimal side effects.
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