Sun Pharma Announces Health Canada Approval of PRWINLEVI®

Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (“Sun Pharma”) announced Health Canada’s approval of PrWINLEVI (clascoterone cream 1%).

WINLEVI is the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older, and the newest Health Canada-approved formulation to target the hormonal component of acne for Canadian patients in 40 years.

“Acne is a common condition due to hormonal triggers. However, there has been a gap in topical acne treatments which impact the hormonal cascade of acne for Canadians,” said Dr. Jerry K.L. Tan, dermatology specialist and founder of The Healthy Image Center in Windsor, Ontario. “I am thrilled that acne patients will soon have a new treatment option.”

“Sun Pharma is committed to providing innovative dermatology medicines for Canadians, which fill the gap for necessary treatment options,” said Abhay Gandhi, North America CEO of Sun Pharma. “We are thrilled to provide a new topical treatment option for the millions of Canadians affected by acne.”

Acne is a highly prevalent dermatological condition, affecting approximately 20 per cent of Canadians. Data shows that acne affects patients’ health-related quality of life and may increase the risk of depression and anxiety.

“Our recent report, Breaking Out: a report on the acne patient experience in Canada, uncovers substantial treatment gaps for individuals with acne,” said Sue Sherlock, executive director of the Acne and Rosacea Society of Canada. “One of our top recommendations for the industry has been to increase access to more treatments. We are pleased to see a new product available for Canadian patients.”

WINLEVI is thought to inhibit the effects of androgen receptors in cells of the sebaceous glands (oilproducing glands in the skin) to help reduce sebum (oil) production and inflammatory cytokines and thus inhibits the androgen cascade.

Instead of a topical approach to acne treatment that focuses on follicular hyperkeratinization, reducing inflammation or exerting antibacterial effects, WINLEVI targets the androgen receptor in the skin to tackle sebum production and inflammation. WINLEVI will be available in Canada this Fall.