FDA approves cream for plaque psoriasis
The U.S. Food and Drug Administration has approved calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora cream; MC2 Therapeutics) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
Approval is based on a phase 3 clinical trial of 794 patients which showed at least a 2-grade improvement from baseline in Physician Global Assessment to “clear” or “almost clear” at 8 weeks in patients treated with Wynzora cream.
“Wynzora Cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead principal investigator in the study, in a press release.
Read the full press release here.