FDA approves plaque psoriasis topical

July 23, 2020

The U.S. Food and Drug Administration has approved Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%, MC2 Therapeutics) for adult with plaque psoriasis. Wynzora is equipped with the MC2 Therapeutics’ patented PAD Technology and is currently under review in the EU.

Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%, MC2 Therapeutics) has been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults, according to a statement from MC2 July 22. 1

The once-daily topical incorporates the company’s patented PAD Technology, which enables Wynzora to remain stable in an aqueous form that quickly absorbs into the skin without feeling greasy, the company says. This technology allows high tolerability and penetration of active ingredients, as well as improved solubility and stability, according to the company.

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“The FDA approval marks an important milestone for patients with plaque psoriasis,” says Jesper J. Lange, CEO of MC2 Therapeutics. “Our PAD Technology has uniquely enabled us to develop Wynzora® Cream with no compromises. It drives the compelling efficacy and safety data of Wynzora Cream and transforms that data into impact for patients through a convenient formulation that allows patients to move on within minutes of a morning routine. It puts patients back in control of therapy and daily life.”

The FDA’s decision to approve Wynzora is backed by positive phase 3 results comparing the drug to Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%, LEO Pharma). The randomized, multicenter, investigator-blind, parallel-group, phase 3 clinical trial enrolled 794 patients with mild-to-moderate plaque psoriasis, ages18 years and older in the United States to evaluate the efficacy and safety of Wynzora versus placebo and active comparator (Taclonex).2

The primary efficacy endpoint included a proportion of patients who achieved Physician Global Assessment (PGA) treatment success at week eight. PGA success in the study is defined as a minimum of a two-grade improvement from baseline in PGA to “clear” or “almost clear”. Results of the trial demonstrate the PGA success difference between Wynzora and Taclonex was 14.6% (95% CI; 7.6%, 21.6%), with results in favor of Wynzora, respectively.1

Additionally, reduction of itch was evaluated and described as a minimum of a four-point improvement in the 11-point peak pruritic numeric rating scale (NRS) from baseline to week four in patients who had at least a baseline peak pruritis NRS score of four. Study results show a larger proportion of patients reached reduction of pruritis in the Wynzora arm (60.3%) versus vehicle (21.4%).1

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“Wynzora is a prime example of what we envision PAD Technology can do to help patients, physicians and payers release the full potential of topical therapies in real world settings,” says Mads Clausen, founder and executive chairman of MC2 Therapeutics.

Most recently, MC2 Therapeutics submitted the Marketing Authorization Application (MAA) with the European Union (EU) in mid-July.1

References:

1. MC2 Therapeutics Announces U.S. Food and Drug Administration Approval of Wynzora® Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for Adults with Plaque Psoriasis. (2020, July 22). Retrieved July 22, 2020, from https://www.mc2therapeutics.com/news/?nid=5f17e20f44e01

2. A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream - Full Text View. (2019, October 29). Retrieved July 24, 2020, from https://clinicaltrials.gov/ct2/show/NCT03308799