Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP.IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) has announced the availability of WINLEVI (clascoterone) cream 1% in the United States (U.S). A first-in-class topical androgen receptor inhibitor, WINLEVI 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 (oilproducing 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.
"Androgen receptor inhibition has long been the missing link in the topical management of acne vulgaris," noted 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."
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