The positive opinion for use of Cosentyx either alone or in combination with methotrexate has been given for the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients who are aged six years and above whose disease has responded insufficiently to, or who cannot tolerate the regular therapy.
ERA and JPsA are progressive and debilitating autoimmune diseases.
While ERA is characterised by joint swelling and pain where tendons and ligaments attach to bone and may manifest with lower back pain or cause tenderness at the palpation of the hips, JPsA is characterised by joint swelling and skin psoriasis and may show nail changes, inflammation of fingers and/or toes or psoriatic skin changes in a first-degree relative.
If these two conditions are not treated, they can lead to high levels of pain and disability.
Novartis global head of Medical Affairs Immunology Todd Fox said: “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.
“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.”
This positive CHMP opinion was given based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomised withdrawal trial indicating significantly longer time to flare in Cosentyx vs placebo in pediatric ERA and JPsA patients.
Safety in this population was found to be consistent with the known safety profile of Cosentyx across approved adult and pediatric indications.
In July 2020, Cosentyx secured EMA approval as a first-line systemic treatment for pediatric psoriasis in patients aged six to 18 years old.
Recently, Cosentyx secured approval in the US and China.
Last year, Cosentyx also got approval in Japan to treat both PsA and psoriasis in pediatric patients aged six years or older, as well as those with generalized pustular psoriasis.
This year, Brazil gave approval to Cosentyx to treat ERA in patients four years or older and JPsA in patients aged two years and older.