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  • Sun Pharma gets...

Sun Pharma gets Australian regulatory nod for acne vulgaris treatment Winlevi

Written By : Susmita Roy |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-19T11:52:03+05:30  |  Updated On 20 March 2024 2:24 PM IST
Sun Pharma European partner Philogen pulls EMA application for skin cancer drug Nidlegy
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Winlevi is approved for the topical treatment of acne vulgaris in people 12 years of age and older.

Mumbai: Sun Pharmaceutical Industries Limited has announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for Winlevi (clascoterone cream 1%).

As stated by Hellen de Kloet, Business Head – Western Europe, Australia and New Zealand, Sun Pharma “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.”

Diana Harbort, President of the Dermatology Division of Cosmo, said, “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.”

Winlevi will be available in Australia this June.

Winlevi is approved for the topical treatment of acne vulgaris in people 12 years of age and older.

Although the exact mechanism of action for Winlevi is unknown, laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles. Androgens are widely recognized as the most important of all hormones in terms of regulating sebum production. Within the skin, androgens bind to androgen receptors, causing increased sebum production and inflammation. In particular, the skin of patients with acne vulgaris produces higher levels of the androgens testosterone and dihydrotestosterone (DHT) than the skin of healthy individuals. Winlevi binds to the androgen receptor competing with androgens such as DHT on cells within the sebaceous gland. Although its precise mechanism of action is unknown, studies suggest Winlevi inhibits androgen receptors in the skin and reduces production of sebum and inflammation. Additionally, Winlevi is rapidly metabolized in the skin, limiting systemic absorption.

Sun Pharma has received from Cosmo the exclusive right to develop and commercialize WINLEVI in US, Japan, Australia, New Zealand, Brazil, Mexico and Russia.

Sun Pharma is a specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Specialty portfolio spans products in dermatology, ophthalmology, and onco-dermatology and accounts for over 16% of company sales. Its manufacturing facilities are spread across six continents.

Read also: Sun Pharma topical acne treatment Winlevi now available in Canada

sun pharmasun pharma newswinleviclascoterone creamacne vulgaris
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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