FDA Approves First Acne Treatment with New Mechanism of Action in 40 Years

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The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1%). Winlevi is the first acne drug with a new mechanism of action to win regulatory approval in the United States in the last 40 years, the company said.

Acne is the most prevalent skin condition in the United States and affects about 50 million people annually. Acne is affected by four distinct pathways, including the production of excess oil, clogged pores, bacteria growth and inflammation. Most current treatments for acne are with a type of drug called retinoids and antibiotics.

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Winlevi is a first-in-class topical androgen receptor inhibitor that tackles the androgen hormone component in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones in acne on increasing sebum production and inflammation.

In pivotal clinical trials, Winlevi demonstrated treatment success and reductions in acne lesions. During studies, Winlevi was shown to inhibit lipid production from oil producing cells (sebocytes) and reduce proinflammatory cytokines, mediators influenced by androgens. Winlevi was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema, the company said.

Cassiopea Chief Executive Officer Diana Harbort said the approval of Winlevi is a milestone for the company, not only as the company’s first approved drug in the United States but also due to the fact that Winlevi is 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,” Harbort said in a statement.

Michael Gold, an investigator for Winlevi and medical director of Gold Skin Care Center and Tennessee Clinical Research Center, called the approval of Winlevi an “exciting breakthrough” in acne treatment and added that the medication is a “game-changer” for patients. Winlevi, he said, offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. After 40 years, the approval of Winlevi provides a “much-anticipated, complementary new approach to treat acne,” Gold said in a statement.

“The approval of Winlevi represents a major milestone for the tens of millions who suffer from acne. We are enthused to have a new first in class topical product with a unique, complementary mechanism of action to treat acne,” Mark Jackson, president of the American Acne & Rosacea Society said in a statement.

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

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