The Food and Drug Administration (FDA) has approved Wynzora® Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%; MC2 Therapeutics) for the treatment of plaque psoriasis in patients aged 18 years of age and older.

Wynzora is a combination of calcipotriene, a synthetic vitamin D3 analogue, and betamethasone dipropionate, a corticosteroid. It utilizes the Company’s proprietary PAD Technology platform that enables the stability of both agents in an aqueous formulation.

The approval was based on data from a multicenter, randomized, parallel-group, phase 3 trial that evaluated the efficacy, safety and convenience of Wynzora in 794 patients with mild to moderate plaque psoriasis. Patients were randomized to receive either Wynzora (n=342), calcipotriene 0.005%/betamethasone dipropionate 0.064% topical suspension (Taclonex; Leo Pharma) (n=337), or vehicle (n=115). 

The primary efficacy end point was the proportion of patients with treatment success at week 8, defined as at least a 2-grade improvement from baseline in the Physician’s Global Assessment (PGA) score and a PGA score equating to “clear” or “almost clear.” 

Results showed that 37.4% of patients treated with Wynzora achieved treatment success at week 8 compared with 3.7% in the vehicle arm (treatment difference 33.7%; 95% CI, 27.4-40.0). Treatment with Wynzora was also found to be noninferior to calcipotriene/betamethasone dipropionate topical suspension, with a PGA treatment success difference of 14.6% (95% CI, 7.6-21.6) in favor of Wynzora.

Additionally, among individuals with at least a peak pruritus numeric rating scale (NRS) score of 4 at baseline, 60.3% of Wynzora-treated patients achieved at least a 4-point improvement in the peak NRS score at week 4, compared with 21.4% of those in the vehicle arm.

Regarding safety, the most common adverse reactions observed with Wynzora were upper respiratory infection, headache, and application site irritation.

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The product will be supplied in 60g tubes and is expected to be available in the first quarter of 2021.

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