Sun Pharma gets approval to sell acne treatment cream Winlevi in Australia

Collaboration with Cosmo enables rights for cream in several countries, says company

India’s Sun Pharmaceutical said on Tuesday the Australian Therapeutic Goods Administration (TGA) has approved its Winlevi (clascoterone) cream 1% for treating acne vulgaris in patients aged 12 and older.

“Winlevi is an exciting addition to our expanding dermatology portfolio of innovative medicines in Australia. Winlevi’s novel mechanism of action will be a welcome addition to the physician’s toolkit while treating acne,” said Hellen de Kloet, business head of Western Europe, Australia and New Zealand at Sun Pharma.

Sun Pharma's collaboration with Cosmo enabled the exclusive development and commercialisation rights for Winlevi in the United States, Japan, Australia, New Zealand, Brazil, Mexico, and Russia. “We are very pleased that Winlevi will soon be available to patients in Australia. This is another achievement in the mission of Cosmo and Sun Pharma to improve the lives of patients affected by skin conditions,” said Diana Harbort, president of the dermatology division of Cosmo, stated,

Winlevi will be available in Australia from June. The cream's active ingredient, clascoterone, operates through a mechanism that competes with androgens, particularly dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles.

The skin of patients with acne vulgaris typically produces higher levels of androgens like testosterone and DHT, leading to increased sebum production and inflammation. Winlevi's ability to bind to androgen receptors, competing with DHT, inhibits this process, thereby reducing sebum production and inflammation.

Sun Pharma, the world's fourth-largest specialty generics company, has a portfolio spanning specialty, generics, and consumer healthcare products.