FDA Approves Otezla for Pediatric Psoriasis

Amgen’s Otezla® (apremilast) has been approved by the U.S. Food and Drug Administration (FDA) for pediatric use in treating moderate to severe plaque psoriasis, making it the first oral option for this condition in children.

The approval, which to patients ages 6 and older who weigh at least 20 kg (44 lb) and are candidates for phototherapy or systemic therapy, is based on results from the randomized, placebo-controlled phase 3 SPROUT trial. According to a press release from the manufacturer, Otezla demonstrated a significant improvement in the static Physician's Global Assessment (sPGA) response at week 16, with 33.1% of patients showing clear or almost clear skin compared to 10.8% in the placebo group (P<0.0001). Common side effects included diarrhea, nausea, and respiratory infections. 

"This is great news for children with this chronic disease," said Leah M. Howard, President and CEO of the National Psoriasis Foundation, in a press statement. She also highlighted the significance of a new oral option, as pediatric patients have typically relied on injections or infusions for systemic treatments.

"For the first time, children and adolescents with moderate to severe plaque psoriasis have an oral option to treat this chronic disease," added Murdo Gordon, Amgen’s Executive VP of Global Commercial Operations in a news release.

Recommended dosages for pediatric patients varies by weight, with 20 mg twice daily for those under 50 kg and 30 mg twice daily for those weighing 50 kg or more.