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The Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion to expand Novartis secukinumab indication to enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA).
The Committee for Medicinal Products for Human Use (CHMP) of the Europeans Medicines Agency (EMA) has issued a positive opinion to expand Novartis secukinumab (Cosentyx) indication to the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients aged 6 years and older who are either intolerant or have an inadequate response to conventional therapy. The drug, if approved, will be used alone or in combination with methotrexate.
“JIA is the most common childhood rheumatic disease, affecting millions of children worldwide. Unfortunately, due to the limitations of current or available treatment options, some patients continue to experience symptoms, with an impact on their life. If approved in Europe, Cosentyx could offer a much-needed, additional effective treatment for the underserved ERA and JPsA patient populations,” stated Ivan Foeldvari, MD, of the Hamburg Centre for Pediatric Rheumatology in Germany.
The Phase 3, double-blind, placebo-controlled, randomized withdrawal study, JUNIPERA, enrolled 86 pediatric patients (aged 2 to 18) with a clinical diagnosis of JPsA or ERA, according to the International League of Associations for Rheumatology classification criteria. The primary endpoint was time to flare between week 12 and week 104 (period 2).
Results showed that patients receiving secukinumab had a significantly longer time to flare when compared with placebo (P<.001) in pediatric patients with JPsA and ERA in the EU. The risk of flare was reduced by 72% during the treatment period (Hazard ratio=0.28, 95% CI: 0.13 to 0.63, p<0.001). There were no new safety complications.
Secukinumab works by inhibiting interleukin-17A, a cytokine that is responsible for the inflammation of plaque psoriasis, psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). In July 2020, the drug received EMA approval for the treatment of pediatric psoriasis in patients aged 6 to 18 years old. It has also been approved in the US, China, Japan, and Brazil to treat a variety of pediatric arthritic conditions.
“The positive CHMP opinion reinforces that children and adults living with immunologic rheumatic and dermatological diseases, and the physicians who treat them, may feel confident in the management of these diseases with Cosentyx,” stated Todd Fox, Global Head of Medical Affairs Immunology at Novartis. “We’re committed to bringing innovative treatments to young people living with rheumatic diseases across the world. With recent approvals in the US, Japan and Brazil, we are one step closer in our ambition to expand Cosentyx to 10 indications in areas of high unmet need.”