FDA approves Wynzora cream for plaque psoriasis

Wynzora cream, MC2 Therapeutics’ plaque psoriasis treatment, has been approved by the FDA for once-daily use in adult patients, according to a press release.

Wynzora cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) is based on PAD technology, which enables stability of both drugs in an aqueous formulation.

The approval was based on phase 3 clinical trial data that found Wynzora showed at least a two-grade improvement in Physician Global Assessment to clear or almost clear after 8 weeks of treatment.

In addition, more patients reached a minimum four-point improvement in Peak Pruritus Numerical Rating Scale with Wynzora cream than vehicle.

“Wynzora cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System in Detroit and lead principal investigator of the study, said in the release.