US FDA approves Winlevi, topical acne treatment from Cassiopea

Cassiopea announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Reportedly, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.

Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation.

“The approval of WINLEVI is an exciting breakthrough in acne treatment. 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. After 40 years, it provides a much-anticipated, complementary new approach to treat acne,” said Michael Gold, Investigator and Medical Director, Gold Skin Care Center and Tennessee Clinical Research Center.”

“Cassiopea’s first-in-class topical androgen receptor inhibitor, WINLEVI, tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation,” informed a company release.

In pivotal clinical trials, WINLEVI demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema.

Diana Harbort, CEO of Cassiopea, said, “This milestone approval marks the introduction of a new class of topical medication in dermatology. Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females. 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 US in early 2021.