Copenhagen, November 20th, 2019 – MC2 Therapeutics, an emerging pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Wynzora™ 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 3 trial demonstrated that Wynzora™ Cream treatment has a substantial and statistically significantly greater efficacy compared to Taclonex® Topical Suspension (“Taclonex®”) 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).
“We are very proud of the overall clinical profile of Wynzora™ Cream and look forward to continuing our interaction with the FDA during the NDA review”, said Jesper J. Lange, President & CEO of MC2 Therapeutics and added “In parallel we will continue our efforts to ensure widespread patient access to Wynzora™ Cream pending approval”.
About Wynzora™ Cream
Wynzora™ Cream is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora™ Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient aqueous formulation. In a phase 3 trial conducted at multiple US sites, Wynzora™ Cream demonstrated a statistically significant greater efficacy compared to Taclonex® Topical Suspension for all endpoints related to physician global assessment (PGA) and PASI. Patients reported superior treatment convenience of Wynzora™ Cream over Taclonex® Topical Suspension, and no adverse reaction was reported in more than 1% of patients treated with Wynzora™ Cream. The unique combination of favorable safety profile, significant clinical efficacy and high convenience of Wynzora™ Cream holds promise to increase treatment adherence and overall patient satisfaction in topical treatment of plaque psoriasis in the real-world setting.
About MC2 Therapeutics
MC2 Therapeutics is a privately held emerging pharmaceutical company focused on topical therapies for chronic inflammatory conditions. Using its proprietary PAD™ Technology – a unique oil-in-water dispersion – MC2 Therapeutics is developing a pipeline of innovative topical therapies designed for unique patient experiences.