Cosentyx receives expanded approvals in the EU for use in childhood arthritic conditions.
Novartis has announced the European Commission has approved Cosentyx, to be used alone or in combination with methotrexate.
The treatment – also known as secukinumab – involves patients in enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories who are six years of age and older, and who have responded inadequately to conventional therapy.
The approval is based on data from the successful phase 3 JUNIPERA trial – a two-year, double-blind, placebo-controlled, randomised withdrawal study during which the condition took significantly longer to flare in Cosentyx versus placebo.
Safety in this paediatric population was also consistent with the known safety profile of Cosentyx across approved adult and paediatric indications.
Novartis is now working closely with regulatory agencies to ensure that eligible European patients can start benefitting from Cosentyx as quickly as possible. In July 2020, Cosentyx received a European Medicines Agency approval as a first-line systemic treatment for paediatric psoriasis in patients aged six to 18 years old and recently received approval in the US and China.
“Cosentyx could now provide a treatment option for eligible patients who continue to struggle with the painful symptoms which negatively impact their quality of life, such as inflammation of the joints, swollen fingers and toes,” said Todd Fox, global head of medical affairs immunology at Novartis. “This approval represents an important step in our ambition to expand Cosentyx to ten indications for children and adults living with rheumatic and dermatologic diseases.”
“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,” added Ivan Foeldvari from the Hamburg Centre for Pediatric Rheumatology.
ERA and JPsA are two forms of juvenile idiopathic arthritis and are progressive, debilitating autoimmune diseases. ERA is characterised by joint swelling and pain where tendons and ligaments attach to bone. JPsA is indicated by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers 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.