The FDA has approved Cassiopea SoA’s Winlevi (clascoterone cream 1%) to treat acne in patients 12 years and older, with a topical characterized by the small European company as the first acne drug in 40 years with a new mechanism of action.

Winlevi, for use twice daily, is a non-antibiotic targeting the androgen receptors that drive sebum production and inflammation. Cassiopea said Winlevi’s exact mechanism of action is unknown but added that laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone, to bind to androgen receptors within the sebaceous gland and hair follicles.

Lainate, Italy-based Cassiopea said it expects Winlevi to become available in the U.S. in early 2021. Pricing has yet to be disclosed.

The approval was based on data from two identical placebo-controlled phase III trials of enrolled 1,440 patients with acne vulgaris that achieved a 2-point reduction and Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) in 16.1% and 18.7%, respectively, of those in the intent-to-treat population receiving Winlevi vs. 7% (p = 0.0012) and 4.7% (p < 0.0001), respectively, in the placebo group.

The absolute change from baseline of non-inflammatory lesion counts was -19.8 in both studies for Winlevi intent-to-treat population vs. -13.7 (p = 0.0046) and 11.3 (p = 0.0001), respectively, for placebo. The absolute change from baseline in inflammatory lesion counts was -19.8 and -20.2, respectively, in the Winlevi intent-to-treat study arms vs. -15.6 (p = 0.0032) and -13.1 (p <0.0001), respectively, for placebo.

The company stock (SIX:SKIN) had a strong day on the Swiss stock exchange as shares surged to close upward 14.78%.

Cosmo Pharmaceuticals SA spun Cassiopea out its dermatology unit in 2015.

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