Cosentyx receives expanded EU authorisation for the treatment of pediatric arthritic diseases.
The European Commission has approved Cosentyx for use alone or in combination with methotrexate, Novartis has said.
The drug – also known as secukinumab – is administered to patients in the enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) age categories who have not responded well to conventional therapy and are at least six years old.
The approval is based on data from the successful phase 3 JUNIPERA trial — a two-year, double-blind, placebo-controlled, randomised withdrawal study in which it took substantially longer for the illness to flare in Cosentyx patients compared to placebo patients.
Safety in this pediatric demographic was similarly consistent with the established safety profile of Cosentyx across all approved indications for adults and children.
Novartis is now collaborating closely with regulatory agencies to expedite the availability of Cosentyx to eligible European patients. Cosentyx was approved as a first-line systemic treatment for paediatric psoriasis in patients aged six to eighteen by the European Medicines Agency in July 2020. It was also recently approved in the United States and China.
Todd Fox, global head of medical affairs immunology at Novartis, stated that “Cosentyx could now give a therapy alternative for eligible patients who continue to battle with unpleasant symptoms that negatively influence their quality of life, such as joint inflammation and swollen fingers and toes.” This approval is a significant step toward our goal of expanding Cosentyx to ten indications for children and adults with rheumatic and dermatologic disorders.
“The approval of Cosentyx is excellent news for European children affected by JPsA and ERA. We can now offer a new treatment target that was not previously available for this condition in children, as well as a reduced administration frequency. Cosentyx joins other approved therapies that may enable children and adolescents to participate in all daily activities, including sports, according to Ivan Foeldvari from the Hamburg Centre for Pediatric Rheumatology.
ERA and JPsA are two types of juvenile idiopathic arthritis, both of which are progressive, severe autoimmune illnesses. ERA is characterized by joint swelling and pain at the attachment points of tendons and ligaments to bone. JPsA is characterized by joint swelling and skin psoriasis, as well as nail alterations, finger or toe inflammation, and psoriatic skin changes in first-degree relatives.
These disorders, if left untreated, can cause severe pain and impairment.