Glenmark Pharmaceuticals (Glenmark) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi in the United Kingdom. The topical treatment for acne vulgaris is approved for use in patients aged 12 years and older. The approval is part of Glenmark’s agreement with Cosmo Pharmaceuticals, which granted Glenmark the rights to distribute the product in Europe and South Africa.
Winlevi is the first topical acne treatment in nearly four decades with a first-in-class mechanism of action. Its active ingredient, clascoterone, is a topical androgen receptor inhibitor that targets androgen receptors in sebaceous glands. Unlike systemic anti-androgen treatments, it can be used safely in both males and females. The treatment is designed to reduce sebum production and intervene early in acne pathogenesis.
Two identical phase 3 clinical trials assessed the efficacy of clascoterone cream, 1 percent, applied twice daily for 12 weeks. The studies demonstrated that the treatment was more effective than vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. The treatment was generally well tolerated.
The licensing agreement between Glenmark and Cosmo Pharmaceuticals was signed in September 2023. The collaboration is focused on expanding the dermatology portfolio of both companies and addressing the needs of patients with acne vulgaris.
“We are thrilled that Winlevi has been approved for the UK market, bringing an innovative approach to acne treatment. This milestone underscores our commitment, alongside Glenmark, to providing patients with breakthrough solutions that address not just the physical symptoms of acne, but also its emotional impact. We take great pride in expanding access to this game-changing therapy and making a real difference in patients’ lives,” said Giovanni Di Napoli, Chief Executive Officer of Cosmo Pharmaceuticals.
“We are excited to receive the approval and bring Winlevi to the UK market, offering patients a new and efficacious treatment for acne,” said Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals. “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.”
“The approval of Winlevi for the UK market marks a crucial milestone in Glenmark’s ongoing efforts to evolve dermatology treatments,” said Xavier Mesrobian, Executive Vice President and Business Head – Europe, Glenmark SA. “We are focused on delivering therapies that address the clinical needs of patients and with Winlevi, we are looking forward to offering an efficacious treatment option for individuals managing acne, a condition that can significantly impact self-confidence and daily life.”
Acne vulgaris is one of the most common skin conditions, affecting more than 90 per cent of the global population at some point in their lives. The condition can have physical and psychological effects, impacting self-esteem and mental health.
