Winlevi (clascoterone 1%), a topical treatment of acne vulgaris in people aged 12 and above, will now be commercialized in the United States and Canada, according to Business Standard.
Sun Pharma, an Indian multinational pharmaceutical company, said that it now has the exclusive right to commercialize Winlevi in the United States and Canada.
Sun Pharma and Cassiopea SpA (Italy-based biotechnology company) announced the expiration of the applicable waiting period under the US Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the exclusive license and supply agreements signed by both companies for Winlevi, per the news outlet.
Following the expiration of the US HSR Act process, Sun Pharma will now have the exclusive right to commercialize Winlevi in the United States and Canada and Cassiopea will be exclusively supplying the product.
Winlevi will be available in the United States in the Q4 calendar 2021.
Abhay Gandhi, CEO, North America, Sun Pharma, said: “The expiration of the applicable waiting period under the HSR Act clears the path for making Winlevi available to patients and healthcare providers in the US and Canada.”
“With Winlevi, a unique product with a new mechanism of action for the topical treatment of acne vulgaris, we have further expanded our basket of innovative products to serve patients better,” he added.
The FDA approved Winlevi last year in August for the topical treatment of acne vulgaris in patients aged 12 and above.
In the United States, acne is the most prevalent skin condition, affecting up to 50 million people annually.
Some of the common side effects of Winlevi include erythema, redness, pruritus, and scaling or dryness. Sun Pharma is the world’s fourth-largest specialty generic pharma company and one of India’s top drug companies.