FDA Approves Sorilux (Calcipotriene) for Adolescent Plaque Psoriasis

May 23, 2019

Vitamin D analog foam indicated for topical treatment of plaque psoriasis in teens.

The FDA has approved Sorilux (calcipotriene, Mayne) for treatment of plaque psoriasis of the scalp and body in patients 12 years and older.

Sorilux’s original 2010 approval was based on evidence from two 8-week placebo-controlled clinical trials in patients with mild-to-moderate plaque psoriasis of the body, and one 8-week placebo-controlled study in patients with moderate plaque psoriasis of the scalp.

Sorilux is a vitamin d analog indicated for topical treatment of plaque psoriasis, to be applied twice daily to affected areas. The treatment is contraindicated for patients with known hypercalcemia.

The most common adverse events reported in clinical trials include erythema or pain at the application site.

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