Glenmark Receives UK MHRA Approval for Winlevi® in Acne Treatment
Glenmark Pharmaceuticals Limited has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi® for the treatment of acne vulgaris in patients aged 12 years and older. Winlevi® is the first topical acne treatment in nearly 40 years with a first-in-class mechanism of action, targeting androgen receptors in sebaceous glands. The active ingredient, clascoterone, is a topical androgen receptor inhibitor that reduces sebum production and intervenes early in acne pathogenesis. Two phase 3 studies demonstrated its effectiveness in reducing non-inflammatory and inflammatory lesion count. Glenmark has in-licensed the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa, reflecting both companies' commitment to expanding their dermatology portfolio and addressing the unmet needs of patients with acne vulgaris.
Key Highlights
- Glenmark received UK MHRA approval for Winlevi®, a topical treatment for acne vulgaris.
- Winlevi® is the first topical acne treatment in nearly 40 years with a first-in-class mechanism of action.
- Clascoterone, the active ingredient in Winlevi®, is a topical androgen receptor inhibitor targeting sebaceous glands.
- Two phase 3 studies demonstrated Winlevi®'s effectiveness in reducing non-inflammatory and inflammatory lesion count.
- Glenmark has in-licensed Winlevi® from Cosmo Pharmaceuticals for distribution in Europe and South Africa.