Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions. Novartis.

“The approval of Cosentyx is very positive news for children affected by JPsA and ERA across Europe. We are now able to offer a new therapeutic target, which was not on the market for this disease in children and also offers a lower frequency of administration. Cosentyx adds to the body of other approved treatments that may provide children and adolescent patients, with the opportunity to participate in all daily activities, and even sports,” said Ivan Foeldvari, M.D., Hamburg Centre for Pediatric Rheumatology, Germany.

ERA and JPsA are two forms of juvenile idiopathic arthritis (JIA) and 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, these diseases can lead to high levels of pain and disability.

The approval is based on data from the Phase III JUNIPERA trial, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal trial showing significantly longer time to flare in Cosentyx versus placebo in pediatric patients with ERA and JPsA. Safety in this pediatric population was consistent with the known safety profile of Cosentyx across approved adult and pediatric indications.