Winlevi is the first FDA-approved acne drug with a first-rate mechanism of action in nearly 40 years, Sun Pharma said in a statement.
It works by inhibiting the effects of androgen receptors in the cells of the sebaceous glands (oil-producing glands in the skin) to help reduce sebum (oil) production and inflammation.
It is suitable for both men and women.
“The launch of WINLEVI in the United States enhances Sun Pharma’s specialty product portfolio and reflects our commitment to meeting patient needs by providing innovative dermatological drugs,” said Abhay Gandhi, CEO of Sun Pharma (North America ).
With its safety and tolerability profile, combined with its proven efficacy in clinical trials, Winlevi has the potential to be an important topical treatment option for the millions of Americans affected by acne vulgaris, he said. he adds.
Acne is the most common skin condition in the United States, affecting up to 50 million Americans each year, the company said citing data.
Prior to the availability of Winlevi, conventional topical approaches to acne treatment focused on either treating follicular hyperkeratinization, reducing inflammation, or exerting antibacterial effects.
In August of this year, Sun Pharma and specialty pharmaceutical company Cassiopea SpA signed an exclusive license and supply agreements for Winlevi cream.
In accordance with the pact, Sun Pharma has the exclusive right to market Winlevi in the United States and Canada. Cassiopea is the exclusive supplier of the product.