FDA Approves WINLEVI Anti-Androgen Therapy for Acne

The approval of WINLEVI (clascoterone cream 1%), a first-in-class topical acne treatment targeting the androgen receptor, brings the first truly new mechanism of action in acne treatment in nearly 40 years.

Winlevi Packaging

The United States Food and Drug Administration (FDA) has approved Cassiopea's WINLEVI (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Clascoterone targets androgens, which drive sebum production and inflammation.

“The approval of WINLEVI is an exciting breakthrough in acne treatment. This game-changing topical drug offers a nonantibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy,” said Michael Gold, MD, investigator and medical director, Gold Skin Care Center and Tennessee Clinical Research Center. “After 40 years, it provides a much-anticipated, complementary new approach to treat acne.”

Although WINLEVI’s exact mechanism of action 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. In pivotal clinical trials, it demonstrated treatment success and reductions in acne lesions in both males and females and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema.

“This milestone approval marks the introduction of a new class of topical medication in dermatology,” said Diana Harbort, CEO of Cassiopea “Dermatologists have said targeting androgen hormonal activity in the skin is the ‘holy grail’ of acne treatment for both males and females. We are proud to bring this new innovation to acne patients. This approval rewards many years of hard work and positions Cassiopea as a leader in dermatology. Now we look forward to expanding our franchise and advancing our next investigational drug candidate for androgenetic alopecia.”

WINLEVI is expected to be available in the United States in early 2021. 


Image: Illustration of WINLEVI brand packaging

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