In studies, a 12-week course of WINLEVI therapy decreased both inflammatory and noninflammatory lesions and significantly enhanced the proportion of patients who successfully completed treatment
Sun Pharma gets Health Canada’s approval for WINLEVI. (Credit: Chermiti Mohamed on Unsplash)
Sun Pharma Canada, a fully-owned subsidiary of Sun Pharmaceutical Industries, announced that Health Canada has approved its WINLEVI (clascoterone cream 1%) for the topical treatment of acne vulgaris (acne).
WINLEVI is said to be the first and only androgen receptor inhibitor indicated for the topical treatment of acne in patients 12 years of age or above.
According to some laboratory studies, WINLEVI’s active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), to target the androgen receptors within the sebaceous gland and hair follicles.
It inhibits androgen receptors in the skin and reduces the production of sebum (oil) and inflammatory cytokines.
Sun Pharma North America CEO Abhay Gandhi said: “Sun Pharma is committed to providing innovative dermatology medicines for Canadians, which fill the gap for necessary treatment options.
“We are thrilled to provide a new topical treatment option for the millions of Canadians affected by acne.”
In studies, a 12-week course of WINLEVI therapy was found related to significant decreases in both inflammatory and noninflammatory lesions. The proportion of patients who successfully complete treatment when compared to vehicles also increased significantly.
In two Phase 3 clinical trials, 18.8% and 20.9% of WINLEVI-treated patients achieved success based on IGA at week 12, compared with 8.7% and 6.6% of patients receiving vehicles.
The mean absolute change from baseline in NILCs at week 12 was found at -20.4 and -19.5 for patients treated with WINLEVI, against -13.0 and -10.8 for patients treated with vehicle.
In addition, the mean absolute change from baseline in ILCs at week 12 was recorded at -19.3 and -20.1 in the WINLEVI groups, versus -15.4 and -12.6 in the two studies’ vehicle groups.
The acne therapy is delivered in 30-gram aluminium tubes. Each gram of WINLEVI has 10 mg of clascoterone in a white to almost white cream.
Sun Pharma said that patients are advised to gently cleanse the affected area. Once the skin has dried, a thin and even layer of WINLEVI is applied to the area that is prone to acne twice a day, in the morning and in the evening.