The US Food and Drug Administration (FDA) has approved Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older, MC2 Therapeutics announces.
Approval is Based on Trial Results
The FDA approval is based on the results of the US Phase 3 clinical trial against active comparator Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). A total of 794 patients were randomized in this tria and the primary efficacy endpoint was the proportion of patients with PGA treatment success at week 8 defined as at least a 2-grade improvement from baseline in PGA to “clear” or “almost clear.” The difference in PGA treatment success to the active comparator was 14.6% (95% CI; 7.6%, 21.6%) in favor of Wynzora Cream.
Reduction of itch, as defined by at least a 4-point improvement in the 11-point peak pruritus numeric rating scale (NRS) from baseline to week 4, was assessed among patients who had at least a peak pruritus NRS score of 4 at baseline. A higher proportion of patients achieved at least a 4-point improvement in the peak pruritus NRS score at week 4 in the Wynzora Cream group (60.3%) compared to vehicle (21.4%), the release explains.
“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 in the study
Studies suggest that more than half of psoriasis patients are dissatisfied with their treatment and that a large proportion of patients are not treated at all, per the release.
“The FDA approval marks an important milestone for patients with plaque psoriasis. 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.”
— MC2 Therapeutics CEO Jesper J. Lange
“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.”
— MC2 Therapeutics Founder and Executive Chairman Mads Clausen
With the US approval, the recent submission of its marketing authorization application of Wynzora Cream in EU, and its ongoing interactions with payers, physicians and patient organizations, MC2 Therapeutics is well on track to launch Wynzora Cream in major territories, the release continues.
In addition, MC2 Therapeutics continues the development of its pipeline of new topical therapies within major chronic inflammatory indications such as atopic dermatitis, uremic pruritus, lichen sclerosus and dry eye.
[Source(s): MC2 Theraputics, Business Wire]