The New Drug Application (NDA) for Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%; MC2 Therapeutics) has been submitted to the Food and Drug Administration (FDA) for the treatment of plaque psoriasis.
Wynzora combines calcipotriene, a vitamin D3 analogue, and betamethasone dipropionate, a corticosteroid, using the Company’s proprietary PAD Technology platform, which enables stability of both of these agents in an aqueous formulation. The NDA includes data from a phase 3 vehicle- and comparator-controlled, parallel-group trial that evaluated the efficacy, safety, and convenience of Wynzora Cream.
Results showed that the trial met its primary (change from baseline in modified Psoriasis Area and Severity Index at Week 8) and secondary (Physician’s Global Assessment at Week 8) end points, demonstrating a statistically significant greater efficacy with Wynzora Cream compared with Taclonex Topical Suspension (calcipotriene [as hydrate] 0.005% and betamethasone dipropionate 0.064%; LEO Pharma). In addition, patients reported superior treatment convenience with the cream, as measured by the Psoriasis Treatment Convenience Scale.
“When we decided to improve the well-established combination of calcipotriene and betamethasone dipropionate by formulating them in a PAD Cream we knew that we were setting a very high bar in our ambition to respond to the needs of patients,” said Jesper J. Lange, CEO of MC2 Therapeutics A/S. “PAD Technology enables us to make PAD Creams with multifold less surfactants compared to conventional creams and lotions thereby optimizing tolerability on sensitive skin.”
For more information visit mc2therapeutics.com.