A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by FDA in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older.

WINLEVI (clascoterone) cream 1% is now available the US, according to Sun Pharmaceutical Industries Limited.

A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by FDA in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older. It is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years.

"The US launch of WINLEVI enhances Sun Pharma's specialty product portfolio and reflects our commitment to meeting patients' needs by providing innovative dermatology medicines," says Abhay Gandhi, CEO, North America of Sun Pharma, in a news release.  "With its safety and tolerability profile, combined with its demonstrated efficacy in clinical trials, WINLEVI has the potential to be an important topical treatment option for the millions of Americans affected by acne vulgaris."

The most common adverse reactions occurring in 7 percent to 12 percent of patients receiving WINLEVI in two clinical trials are, erythema (reddening), pruritus (itching), and scaling/dryness. Additionally, edema, stinging, and burning occurred in at least 3 percent of patients and were reported in a similar percentage of participants treated with vehicle.

"Androgen receptor inhibition has long been the missing link in the topical management of acne vulgaris," notes Julie Harper, MD, founding director and past president of the American Acne and Rosacea Society. "Androgens are the most important hormone in regulating sebum production – which is a major cause of acne in both males and females – yet WINLEVI is the first FDA-approved topical therapy to address this and does so without inducing the systemic side effects associated with oral androgen receptor inhibitors. The availability of WINLEVI is thus a welcome acne treatment option."