Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab), used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
“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,” said Ivan Foeldvari, M.D., Hamburg Centre for Pediatric Rheumatology, Germany.
ERA and JPsA are progressive, debilitating autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with lower back pain or tenderness at the palpation of the hips. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative. If left untreated, they can lead to high levels of pain and disability.
“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,” said 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.”
The positive CHMP opinion is based on data from the Phase III JUNIPERA study, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial showing significantly longer time to flare in Cosentyx vs placebo (P<.001) in pediatric ERA and JPsA patients16. Safety in this pediatric population was consistent with the known safety profile of Cosentyx across approved adult and pediatric indications9.
This CHMP recommendation supports Novartis ongoing commitment to the pediatric community across a range of inflammatory conditions. In July 2020, Cosentyx received EMA approval as a first-line systemic treatment for pediatric psoriasis in patients aged 6-18 years old and recently received approval in the US and China. In 2021, Cosentyx was also approved in Japan to treat both PsA and psoriasis in pediatric patients aged 6 years or older, as well as those with generalized pustular psoriasis. Earlier this year, Cosentyx was also approved in Brazil to treat ERA in patients 4 years or older and JPsA in patients aged 2 years and older.
