FDA Accepts MC2 Therapeutics’ NDA for Topical Plaque Psoriasis Treatment

November 26, 2019

The new treatment is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis.

MC2 Therapeutics, a pharmaceutical company focused on novel PAD Technology-based topical therapies for chronic inflammatory conditions, announced on Nov. 20, 2019 that FDA accepted its new drug application (NDA) for Wynzora Cream (calcipotriene and betamethasone dipropionate) for the treatment of plaque psoriasis.

According to the company, the new treatment is the first cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. In a Phase III trial, the drug showed a higher efficacy compared to Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate), a topical treatment for plaque psoriasis by Leo Pharma.

“We are very proud of the overall clinical profile of Wynzora Cream and look forward to continuing our interaction with [FDA] during the NDA review,” said Jesper J. Lange, president and CEO of MC2 Therapeutics, in a company press release. “In parallel we will continue our efforts to ensure widespread patient access to Wynzora Cream pending approval.”

Source: MC2 Therapeutics