FDA Approves Wynzora® Cream for Plaque Psoriasis

Plaque psoriasis is the most common type of psoriasis, with approximately 80 percent to 90 percent of patients with psoriasis developing plaques.[1] On July 22, 2020, the U.S. Food and Drug Administration approved Wynzora® cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for the treatment of plaque psoriasis in adult patients.

Wynzora® cream marks the first cream formulation of a vitamin D based treatment (calcipotriene) and a corticosteroid (betamethasone dipropionate). Using proprietary PAD™ Technology, researchers developed a way to enable stability of both treatments in a cream formulation that is meant to be convenient for patients to use.

Data from phase 3 trials of Wynzora® cream showed it to have statistically significant treatment efficacy as well as favorable patient-reported outcomes, compared to another calcipotriene and betamethasone dipropionate topical treatment.

Manufacturer, MC2 Therapeutics, is also investigating drug candidates for other indications such as atopic dermatitis.

[1] https://www.aad.org/public/diseases/psoriasis/what/overview