FDA Approves Secukinumab for ERA and PsA Treatment in Pediatric Patients


Novartis receives approval for Cosentyx, their biologic treatment for enthesitis-related arthritis and juvenile psoriatic arthritis, in children and adolescents.

Secukinumab (Cosentyx), a biologic treatment developed by Novartis for enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA), has been approved by the FDA for children and adolescents. Secukinumab is now the only biologic treatment in the US that’s approved for this age group.

The approvals are supported by JUNIPERA trial data that showed secukinumab reduced flare risk when compared with placebo and displayed improvement in disease activity for both enthesitis-related arthritis and psoriatic arthritis in pediatric patients observed over 2 years.

The safety profile was consistent in the pediatric population as with the known safety profile for treatment in adults. Secukinumab is approved for children 4 years of age and older with enthesitis-related arthritis and 2 years of age and older for children with psoriatic arthritis.

These marked the second and third approvals for secukinumab in the pediatric population, granting secukinumab with a total of 5 indications in rheumatology and dermatology.

“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” Hermine Brunner, MD, Cincinnati Children’s Hospital said in a statement. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”

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