Posted by Michael Wonder on 23 Jul 2020
MC2 Therapeutics announces U.S. Food and Drug Administration approval of Wynzora (calcipotriene 0.005% and betamethasone dipropionate 0.064% cream) for adults with plaque psoriasis
22 July 2020 - MC2 Therapeutics announced today that the U.S. FDA has approved Wynzora (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% cream) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
The FDA approval is based on the results of the US Phase 3 clinical trial against active comparator Taclonex topical suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%).
A total of 794 patients were randomised in this trial and the primary efficacy endpoint was the proportion of patients with PGA treatment success at week 8 defined as at least a 2 grade improvement from baseline in PGA to “clear” or “almost clear”. The difference in PGA treatment success to the active comparator was 14.6% (95% CI; 7.6%, 21.6%) in favour of Wynzora cream.
