FDA Approves Cosentyx for Pediatric Patients

On June 1, 2020, the U.S. Food and Drug Administration (FDA) approved the use of Cosentyx® (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 years old and older who are candidates for systemic therapy or phototherapy. Cosentyx® was previously approved for the treatment of plaque psoriasis in adults.

Cosentyx®, manufactured by Novartis Pharmaceuticals Corporation, is a biologic treatment that inhibits interleukin-17A (IL-17A). IL-17A is a cytokine involved in the inflammation observed in patients with psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis and active non–radiographic axial spondyloarthritis.[1]

“Pediatric psoriasis has tremendous impact on affected children, adolescents, and their families. But the revolution of therapy in psoriasis was much delayed in pediatrics, with only a few biologic agents studied and approved in teens and children. The addition of secukinumab approval for moderate to severe plaque psoriasis in children 6 years and older is important— a newer generation biologic agent targeting IL-17A with data showing excellent efficacy with good tolerance expands our armamentarium for treatment,” says Lawrence Eichenfield, M.D. the Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego and Vice-Chair and Professor of Dermatology and Pediatrics at the University of California San Diego School of Medicine

This approval is based on two Phase 2 studies that evaluated the use of Cosentyx® in children between the ages of 6 and less than 18 with plaque psoriasis. This clinical trial evaluation was needed, as it is already approved for use in adults. The first study, which evaluated efficacy and safety, showed Cosentyx® reduced psoriasis severity at Week 12 compared with placebo and the safety profiles reported in the 2 trials were consistent with the safety profile reported in adult plaque psoriasis trials.

“Having treatment options is important to practitioners and patients! We have our traditional TNF-blockers, 1 approved down to 4 years of age, and an IL-12-23 inhibitors now indicated down to 6 years of age, and with secukinumab joining ixekizumab, two IL-17A inhibitors approved for ages 6 and older, we expanded choices of biologics with varying dosage schedules. Every patient has their own story, type of psoriasis and extent, and versatility in systemic treatments beyond traditional immunosuppressives (such as methotrexate and cyclosporine) helps us to minimize the disease impact,” says Dr. Eichenfield.