Posted by Michael Wonder on 17 Jul 2020
MC2 Therapeutics announces submission of marketing authorisation application in EU for Wynzora cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))
16 July 2020 - MC2 Therapeutics today announced the submission of its marketing authorisation application in EU for Wynzora cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate)) for the treatment of plaque psoriasis.
The European filing follows the submission of a new drug application on Wynzora cream to the U.S. FDA in September 2019.
The application is supported by two comprehensive Phase 3 trials including a trial conducted in EU evaluating the efficacy and safety of Wynzora cream compared to vehicle and active comparator Dovobet/Daivobet gel in patients with psoriasis vulgaris. The trial enrolled 490 patients at 32 clinical centres.
