July 22, 2020

The U.S. FDA has approved Wynzora® (calcipotriene 0.005%/betamethasone dipropionate 0.064%) cream, manufactured by MC2 Therapeutics, to provide topical treatment of plaque psoriasis in adults. It is the first cream formulation of a vitamin D based treatment (calcipotriene) and a corticosteroid (betamethasone dipropionate), and was created using MC2’s proprietary PAD™ Technology.

Plaque psoriasis is a chronic inflammatory condition that can lead to red, scaly, itchy, and broken skin. It is believed to affect more than 8 million people in the United States and is the most common type of psoriasis. Over time, patients who have plaque psoriasis may also develop psoriatic arthritis, which occurs when inflammation begins to affect areas of the body such as the joints and spine. Psoriasis occurs when the body’s immune system becomes overactive and begins to attack healthy tissues—in the case of plaque psoriasis, the skin.

In a clinical trial, Wynzora was 14.6% more successful in treating plaque psoriasis than Taclonex® (calcipotriene 0.005%/betamethasone dipropionate 0.064%) topical suspension, a current standard of care. Treatment success was defined as at least a two-grade improvement from baseline in Physician Global Assessment, a scale used to evaluate the severity of plaque psoriasis, to “clear” or “almost clear.” Wynzora also helped reduce itching caused by plaque psoriasis.

Recommended dosing is no more than 100g per week. Wynzora should be applied to affected areas once daily for up to eight weeks. Patients should stop treatment once the plaque psoriasis is under control, unless otherwise instructed by their healthcare provider.

MC2 has not announced a launch date or pricing plans.

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