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Topical androgen receptor inhibitor approved by FDA for acne


Clascoterone cream 1% (Winlevi, Cassiopea), a first-in-class androgen receptor inhibitor, has been approved by the U.S. FDA for treatment of acne vulgaris in patients 12 years and older.

Clascoterone cream 1% (Winlevi, Cassiopea) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of acne vulgaris in patients 12 years and older, the company announced.

Clascoterone cream 1%, a first-in-class androgen receptor inhibitor, restricts sebum production and inflammation caused by androgen hormones.1

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"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," says Michael Gold, M.D., 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."

The topical incorporates the first new mechanism of action (MOA) in acne treatment in almost 40 years, according to the company. Clinical studies suggest the treatment’s active ingredient, clascoterone, competes with androgens such as dihydrotestosterone (DHT) by binding to the androgen receptors located in the hair follicles and sebaceous glands.1

The approval is backed by positive data from clinical studies investigating the topical, in which clascoterone cream 1% reduced the number of acne lesions and was well tolerated. The most commonly reported local skin reaction reported was mild erythema.1

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"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,” says Diana Harbort, CEO of Cassiopea. “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."

The treatment is expected to be available in the United States beginning early 2021, according to the company.1


1. Cassiopea. (2020, August 27). Cassiopea Receives FDA Approval for Winlevi® (clascoterone cream 1%), First-in-Class Topical Acne Treatment Targeting the Androgen Receptor. Retrieved August 27, 2020, from https://www.prnewswire.com/news-releases/cassiopea-receives-fda-approval-for-winlevi-clascoterone-cream-1-first-in-class-topical-acne-treatment-targeting-the-androgen-receptor-301119454.html

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