Sun Pharma Receives Australian TGA Approval for Winlevi

Sun Pharma receives Australian TGA approval for Winlevi to treat acne vulgaris in patients 12 years of age and older

Overview

Sun Pharmaceutical Industries Limited announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for Winlevi (clascoterone cream 1%). Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Words from Sun Pharma Leaders

• 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.”

 
Availability- According to a company press release, Winlevi will be available in Australia by this June.

Indication and Mechanism

• 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. 

About Androgens

• 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: MOA

• 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 receptors5 in the skin and reduces production of sebum and inflammation. 
• Additionally, Winlevi is rapidly metabolized in the skin, limiting systemic absorption. 

Other Exclusive Rights

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

About Sun Pharma

• Sun Pharma is the world’s fourth largest specialty generics company with presence in specialty, generics and consumer healthcare products. 
• It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as global emerging markets.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!