Cassiopea’s Winlevi Approved as Topical Acne Treatment

The FDA has approved Cassiopea’s Winlevi (clascoterone cream 1 percent) to treat acne in patients 12 years and older.

Winlevi is the first novel approach to acne approved in 40 years. It targets the androgen hormone of acne, which drives sebum production and inflammation. In clinical trials, the drug demonstrated treatment success, reductions in acne lesions and was well-tolerated when used twice a day.

Cassiopea plans to launch the product in the U.S. in early 2021.