Sun Pharmaceuticals announced the availability of Winlevi (clascoterone) cream 1% in the United States (U.S). A first-in-class topical androgen receptor inhibitor, it was approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older.

Winlevi is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years. It works by inhibiting the effects of androgen receptors in cells of the sebaceous glands (oil producing glands in the skin) to help reduce sebum (oil) production and inflammation. It is suitable for use in both males and females.

“The U.S. launch of Winlevi enhances Sun Pharma’s specialty product portfolio and reflects our commitment to meeting patients’ needs by providing innovative dermatology medicines,” said Abhay Gandhi, CEO, North America of Sun Pharma. “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% to 12% 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% of patients and were reported in a similar percentage of participants treated with vehicle.

The most prevalent skin condition in the U.S., acne affects up to 50 million Americans annually. Prior to the availability of Winlevi, conventional topical approaches to acne treatment focused on either addressing follicular hyperkeratinization, reducing inflammation, or exerting antibacterial effects. While such approaches are all key to managing acne, to date, none of the currently available topical therapies for acne has focused on inhibiting sebum production resulting from androgen stimulation in sebaceous

gland cells.