Novartis Cosentyx receives positive CHMP opinion for use in childhood arthritic conditions
Biotech

Novartis Cosentyx receives positive CHMP opinion for use in childhood arthritic conditions

Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU

  • By IPP Bureau | May 21, 2022

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.”

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