Amgen’s Otezla approved for pediatric plaque psoriasis

This marks a significant milestone as Otezla is the first FDA-approved oral medication for children and adolescents in this category. The approval, granted earlier this year by the U.S. Food and Drug Administration (FDA), is a breakthrough for young patients who are candidates for phototherapy or systemic therapy and weigh at least 20 kg (44 lbs). Prior to this, treatment options for this population were limited to injections or infusions.

Gordon highlighted the significance of this approval by noting that Otezla has been prescribed to over one million adults globally in the past decade.

“For the first time, children and adolescents with moderate to severe plaque psoriasis and their caregivers have an oral option to treat this chronic disease,” said Murdo Gordon, executive vice president of global commercial operations at Amgen.

Plaque psoriasis is a chronic immune-mediated disease characterized by highly visible, itchy, and often painful skin lesions. Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation, emphasized the importance of this new treatment option: “The addition of an oral treatment option with a well-established safety profile is great news for children with this disease and their families.”

The FDA’s approval was based on data from the Sprout study, a phase 3, multicenter, randomized, placebo-controlled, double-blind trial evaluating Otezla’s efficacy and safety in pediatric patients. The study met its primary endpoint, showing a significant improvement in the static Physician’s Global Assessment (sPGA) response at week 16, with 33.1% of patients treated with Otezla achieving a clear or almost clear score, compared to just 10.8% for those on placebo. The safety profile in pediatric patients was consistent with that observed in adults.