INDIA—Sun Pharmaceutical, based in India, has announced that the Australian Therapeutic Goods Administration (TGA) has approved its Winlevi (clascoterone) cream 1% for treating acne vulgaris in patients aged 12 and older.

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.

This approval was made public by Hellen de Kloet, the business head of Western Europe, Australia, and New Zealand at Sun Pharma, who expressed her excitement, noting that Winlevi is poised to expand Sun Pharma’s dermatology portfolio of innovative medicines in Australia.

 She went on to say that Winlevi’s novel mechanism of action will be a welcome addition to the physician’s toolkit while treating acne.

Sun Pharma’s collaboration with Cosmo enabled the exclusive development and commercialization rights for Winlevi in the United States, Japan, Australia, New Zealand, Brazil, Mexico, and Russia.

Diana Harbort, president of the dermatology division of Cosmo, on her part, was pleased that Winlevi will soon be available to patients in Australia.

 According to her, this is another achievement in the mission of Cosmo and Sun Pharma to improve the lives of patients affected by skin conditions.

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

Winlevi will be available in Australia from June 2024.

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