Sun Pharma to launch WINLEVI in U.S.

Sun Pharma to launch WINLEVI in U.S.

Sun Pharmaceutical Industries Limited announced today that WINLEVI (clascoterone) cream 1% is now available in the United States (U.S). The FDA approved WINLEVI, a first-in-class topical androgen receptor inhibitor, in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older.

WINLEVI is the first acne drug approved by the FDA in nearly 40 years with a first-in-class mechanism of action.

It reduces sebum (oil) production and inflammation by inhibiting the effects of androgen receptors in cells of the sebaceous glands (oil-producing glands in the skin).

It can be used on both males and females.

"The launch of WINLEVI in the United States expands Sun Pharma's specialty product portfolio and demonstrates our commitment to meeting patients' needs by providing innovative dermatology medicines," said Abhay Gandhi, Sun Pharma's CEO, North America. "WINLEVI has the potential to be an important topical treatment option for the millions of Americans affected by acne vulgaris due to its safety and tolerability profile, as well as its demonstrated efficacy in clinical trials."

In two clinical trials, the most common adverse reactions were erythema (reddening), pruritus (itching), and scaling/dryness, which occurred in 7% to 12% of patients receiving WINLEVI. Furthermore, edoema, stinging, and burning were reported in at least 3% of patients and a similar percentage of participants treated with vehicle.

Acne is the most common skin condition in the United States, affecting up to 50 million people each year.

Prior to the introduction of WINLEVI, conventional acne treatments focused on either addressing follicular hyperkeratinization, reducing inflammation, or exerting antibacterial effects. While all of these approaches are important for acne management, none of the currently available topical acne treatments have focused on inhibiting sebum production caused by androgen stimulation in sebaceous gland cells.

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