Cosentyx® (secukinumab) from Novartis is now FDA approved for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy. This is the first approval for Cosentyx in a pediatric population in the US. 

Cosentyx is approved for dosing of 75mg or 150mg, depending on the child’s weight, every four weeks after an initial loading regimen. After initial counseling and proper training in injection technique, Cosentyx can be administered by an adult caregiver outside of a healthcare provider’s office via a single-dose prefilled syringe or Sensoready® pen.

“Treating moderate to severe plaque psoriasis in children can be complicated, as we need to balance the ability of a treatment to provide symptom relief while considering the safety profile as the top priority,” says John Browning, MD, FAAD, FAAP, MBA, clinical trial investigator, Adjunct Associate Professor of Pediatrics and Dermatology at the University of Texas Health, San Antonio. “In the pediatric pivotal study, the majority of patients treated with Cosentyx were able to achieve clear or almost clear skin with a safety profile consistent with previous clinical trials in adults. Due to the systemic nature of the disease, Cosentyx is a welcome addition as a treatment option for families dealing with this challenging condition.”

This Cosentyx approval is based on two phase 3 studies evaluating the use of Cosentyx in children aged 6 to <18 years with plaque psoriasis. The safety profile reported in these trials was consistent with the safety profile reported in adult plaque psoriasis trials. No new safety signals were observed. 

“Today’s FDA approval represents an important milestone for Cosentyx demonstrating our commitment to help meet the needs of pediatric plaque psoriasis patients and their families,” said Victor Bulto, President, Novartis Pharmaceuticals Corporation. “With more than 400,000 patients treated in over 100 countries worldwide, this expanded indication builds on the established safety and efficacy profile of Cosentyx.” 

In a 52-week (236 weeks total), randomized, double-blind, placebo- and active-controlled study that included 162 children six years of age and older with severe plaque psoriasis, Cosentyx reduced psoriasis severity at Week 12 compared with placebo. A second phase 3 study was a randomized open-label, 208-week trial of 84 subjects six years of age and older with moderate to severe plaque psoriasis. 

“Living with psoriasis is challenging, and can be highly stressful for children and adolescents,” said 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.”