FDA approves topical antiandrogen cream clascoterone for acne

Written by Dr. Kamal Kant Kohli Published On 2020-08-28T11:12:51+05:30 | Updated On 28 Aug 2020 11:12 AM IST

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

Clascoterone is a topical androgen receptor inhibitor and it targets the androgen hormones that contribute to acne by inhibiting serum production and inflammation.

Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation2. Topical treatment options that target androgens, which largely drive sebum production and inflammation, presented a significant unmet need in the acne treatment market until now.

The approval of Clascoterone was based in part on a pair of phase 3, double-blind, vehicle-controlled, 12-week, randomized trials including 1,440 patients aged 9 years and older with moderate to severe facial acne. The findings were published in April, in JAMA Dermatology .

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.

"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." said 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."

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 inflammation3.

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. 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."

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Source : FDA

Dr. Kamal Kant Kohli