Sun Pharma arm presents phase 3 data for acne vulgaris cream WINLEVI at AAD meeting

Mumbai: Sun Pharmaceutical Industries Limited has announced that the Company's wholly owned U.S. subsidiary presented data from two pivotal Phase 3 clinical trials of WINLEVI (clascoterone) cream 1% for the topical treatment of acne vulgaris (acne).

The results, which showed favorable safety and efficacy data in patients 12 years of age and older with acne, were reported in a poster podium presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston, Massachusetts. 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. Although its exact mechanism of action is unknown, laboratory studies suggest that WINLEVI 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 data presented at AAD 2022 add to the growing body of evidence supporting the use of WINLEVI as a foundational acne treatment," said Nicholas Squittieri, MD, Associate Vice President of Medical Affairs at Sun Pharma, and co-author of the AAD poster presentation. "We look forward to further exploring its clinical utility as we conduct more studies and data analyses." "Before WINLEVI became available, there was no topical medication available that was able to reduce sebum production, which is a major cause of acne," commented Hilary Baldwin, MD, Medical Director of the Acne Treatment and Research Center in Brooklyn, NY, and past president of the American Acne and Rosacea Society (AARS). "It is therefore encouraging to see favorable efficacy and safety data results from the latest analysis of the WINLEVI Phase 3 clinical trials. This data should also provide dermatologists with confidence that they can use WINLEVI to treat both females and males with acne."