Drug major Sun Pharmaceutical Industries Ltd on Monday, June 19, said its wholly-owned subsidiary Sun Pharma Canada Inc has received 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, the company said in an exchange filing.
"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.
Acne is a highly prevalent dermatological condition, affecting approximately 20 percent of Canadians. Data shows that acne affects patients’ health-related quality of life and may increase the risk of depression and anxiety.
Abhay Gandhi, North America CEO of Sun Pharma, said the company is committed to providing innovative dermatology medicines for Canadians, which fill the gap for necessary treatment options.
WINLEVI is thought to inhibit the effects of androgen receptors in cells of the sebaceous glands (oil-producing glands in the skin) to help reduce sebum (oil) production and inflammatory cytokines, and thus check 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 in their autumn season.
In clinical studies, a 12-week course of WINLEVI therapy was associated with significant reductions in both inflammatory and non-inflammatory lesions, as well as a significant increase in the number of patients achieving treatment success when compared to vehicle.
