Cassiopea receives FDA approval for clascoterone cream 1%

Lainate, Italy-based Cassiopea says FDA approved its clascoterone cream 1% (Winlevi) topical acne treatment for patients aged 12 years and older. Researchers say treatment options that target androgens, which largely control sebum production and inflammation, presented a significant unmet need in the acne treatment market. Michael Gold, MD, investigator and medical director, Gold Skin Care Center and Tennessee Clinical Research Center, says: “This game-changing topical drug offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy.” In clinical trials, the use of clascoterone cream 1% led to reductions in acne lesions and was well tolerated when used twice a day. The most commonly observed local skin reaction was mild erythema.