FDA approves Cosentyx for kids aged 6 and older

The US Food and Drug Administration has approved Cosentyx® (secukinumab) from Novartis Pharmaceuticals Corporation for the treatment of moderate-to-severe plaque psoriasis in children aged 6 years and older who are candidates for phototherapy or systemic therapy. It’s the first pediatric approval for secukinumab in the United States. The approved pediatric doses are 75 mg or 150 mg, dependent on the child’s weight, and is administered via subcutaneous injection every 4 weeks following an initial loading dose. Following counseling and training in injection, secukinumab can be given to a child by an adult caregiver.

The approval was based on the results from 2 trials. The first trial was 52 weeks and was a randomized, double-blind, placebo- and active-controlled study of 16 randomized, double-blind, placebo- and active-controlled study of children aged 6 years of age who had severe plaque psoriasis. In the trial, secukinumab reduced psoriasis severity at Week 12 when compared to the placebo. The other Phase III study was a randomized open-label, 208-week trial of 84 children aged 6 years and older who had moderate-to-severe plaque psoriasis.

The most common side effects seen with secukinumab are upper respiratory infections, diarrhea, and cold symptoms.

In a release for the approval, Randy Beranek, President and CEO, National Psoriasis Foundation. "Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis."

Reference

1. Novartis Pharmaceutical Corporation. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis. Published June 1, 2021. Accessed June 2, 2021. https://www.prnewswire.com/news-releases/novartis-cosentyx-receives-fda-approval-for-treatment-of-children-and-adolescents-with-moderate-to-severe-plaque-psoriasis-301303365.html