Winlevi Approved to Treat Acne

August 27, 2020 – The U.S. FDA has approved Winlevi® (clascoterone cream 1%), manufactured by Cosmo Pharmaceuticals, to treat acne vulgaris in patients who are at least 12 years of age. Winlevi is the first in a new class of acne drugs known as topical androgen receptor inhibitors.

Acne affects an estimated 50 million people in the United States annually. It often begins in puberty and is found in approximately 85% of people between the ages of 12 and 24. The root cause is often overactive sebaceous oil glands in the skin. The excess oil production leads to pores becoming clogged with oil and dead skin cells, creating a favorable environment for bacteria. Other contributing factors include hormones, genetics, and diet.

In clinical trials, Winlevi reduced the number of acne lesions compared to baseline and was well tolerated by patients. Under the recommended dosing, patients should cleanse the affected skin and then apply a thin layer of approximately 1g of Winlevi twice daily. Winlevi works by limiting the effects of androgen hormones that play a role in acne development.

Cosmo Pharmaceuticals plans to launch the product in 2021. Pricing plans are not yet available.