Winlevi Cream Approved for Acne Vulgaris

The first-in-class topical acne treatment targets the androgen receptor.

The Food and Drug Administration (FDA) has approved Winlevi® (clascoterone cream 1%; Cassiopea) for the topical treatment of acne vulgaris in patients 12 years and older.

Clascoterone, a topical androgen receptor inhibitor, targets androgen receptors at the application site, inhibiting the local effects of dihydrotestosterone, a key driver of acne lesion development. The approval was based on data from 2 identical, multicenter, double-blind, vehicle-controlled phase 3 trials (Trial 1 and Trial 2) that evaluated the efficacy and safety of Winlevi in 1440 patients with facial acne vulgaris. Patients were randomized 1:1 to receive Winlevi cream or vehicle cream applied twice daily for 12 weeks. 

Efficacy was assessed by the proportion of patients with at least a 2-point reduction in Investigator’s Global Assessment (IGA) compared to baseline and an IGA score of 0 (clear) or 1 (almost clear), as well as absolute change and percent change from baseline in noninflammatory and inflammatory lesions.

Results showed that at 12 weeks, IGA success rates were 18.8% and 20.9% with Winlevi cream compared with 8.7% and 6.6% with vehicle cream, respectively. Moreover, treatment with Winlevi was associated with statistically significant reductions in both inflammatory and noninflammatory lesions. As for safety, the most common adverse reactions reported were erythema/reddening, pruritus and scaling/dryness.

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

The Company expects to launch Winlevi in early 2021.

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Cassiopea receives FDA approval for Winlevi® (clascoterone cream 1%), first-in-class topical acne treatment targeting the androgen receptor. Accessed August 27, 2020.