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.
The product will be supplied in 60g tubes and is expected to be available in the first quarter of 2021.
For more information visit wynzora.com.