Otezla (apremilast) available in the U.S. for moderate to severe pediatric plaque psoriasis

Earlier this year, FDA approved Otezla for the treatment of moderate to severe plaque psoriasis in children and adolescents ages ≥6 who weigh ≥20 kg (44 lb) and are candidates for phototherapy or systemic therapy. The drug is the first oral medication that is FDA-approved for plaque psoriasis in the pediatric population. FDA approval was based on results from SPROUT, a phase 3, multicenter, randomized, placebo-controlled, double-blind study in which the primary endpoint at week 16 was met with a 33.1% static Physician's Global Assessment (sPGA) response for Otezla vs. 10.8% for placebo.