Sun Pharmaceutical Industries Limited (Sun Pharma) has achieved a significant milestone in dermatology with the Australian Therapeutic Goods Administration (TGA)’s recent approval of Winlevi (clascoterone cream 1%). Indicated for the topical treatment of acne vulgaris in patients aged 12 and older, Winlevi introduces a novel mechanism of action to the Australian market, enriching Sun Pharma’s dermatology portfolio.

Hellen de Kloet, Business Head – Western Europe, Australia, and New Zealand at Sun Pharma, expressed enthusiasm about the approval, stating, “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.” This sentiment is echoed by Diana Harbort, President of the Dermatology Division of Cosmo, highlighting the achievement as a step forward in the mission of Cosmo and Sun Pharma to enhance the quality of life for patients with skin conditions.

Set to be available in Australia by June, Winlevi is designed for the topical treatment of acne vulgaris, offering a new option for those 12 years of age and older. Although Winlevi’s exact mechanism of action remains under investigation, it is understood that the active ingredient, clascoterone, competes with androgens, such as dihydrotestosterone (DHT), targeting the androgen receptors within the sebaceous glands and hair follicles. This action is believed to mitigate sebum production and inflammation, crucial factors in the development of acne.

The skin of individuals with acne vulgaris has been shown to produce higher levels of androgens like testosterone and DHT compared to those without the condition. Winlevi’s competitive binding to the androgen receptor plays a significant role in its therapeutic effect, inhibiting androgen receptors in the skin, thereby reducing sebum production and inflammation.

With exclusive rights to develop and commercialize Winlevi in regions including the US, Japan, Australia, New Zealand, Brazil, Mexico, and Russia, Sun Pharma’s approval by the TGA is a pivotal step in bringing this innovative acne treatment to patients across Australia.

The TGA approval of Sun Pharma’s Winlevi represents a significant advancement in the treatment of acne vulgaris. By targeting the androgen receptors with a novel mechanism of action, Winlevi offers a promising new avenue

for dermatologists and patients alike in the battle against acne. This innovative approach not only broadens the spectrum of available treatments but also emphasizes the importance of targeted therapy in dermatology. As Winlevi becomes available in Australia, it’s expected to set new standards in acne care, reflecting Sun Pharma’s commitment to addressing unmet needs in skin health and reinforcing the role of advanced research in developing effective dermatological solutions.

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