FDA accepts Wynzora NDA for plaque psoriasis

Privately-held Danish company MC2 Therapeutics today announced that the US Food and Drug Administration has accepted for review its New Drug Application (NDA) for Wynzora Cream (calcipotriene and betamethasone dipropionate; previously dubbed MC2-01 Cream).

MC2 Therapeutics is seeking marketing approval for Wynzora Cream for the treatment of plaque psoriasis. The FDA has set July 20, 2020 as the Prescription Drug User Fee Act (PDUFA) action date.

MC2 Therapeutics’ NDA for Wynzora Cream is comprised of extensive quality, non-clinical and clinical data. Specifically, data from the pivotal Phase III trial demonstrated that Wynzora Cream treatment has a substantial and statistically-significantly greater efficacy compared to  LEO Pharma’s Taclonex (calcipotriene and betamethasone dipropionate) topical suspension based on treatment success defined as a minimum two-point decrease in the Physician Global Assessment (PGA) score to clear or almost clear disease (40.1% versus 24.0%, p < 0.0001).