FDA approves Novartis’ Cosentyx for psoriatic arthritis patients

pharmafile | December 23, 2021 | News story | |   

The FDA has approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in children four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. This makes Cosentyx the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in paediatric patients in the US.

These are the second and third approvals for Cosentyx in a paediatric population in the US, bringing the treatment to a total of five indications across rheumatology and dermatology.

ERA and JPsA are autoimmune diseases, and are subtypes of juvenile idiopathic arthritis (JIA). ERA is characterised by joint swelling and pain, where tendons and ligaments attach to the bone. This tends to cause lower back pain and tenderness at the hips. JPsA is characterised by joint swelling and skin psoriasis, and may cause nail changes, inflammation of the fingers and/or toes, or psoriatic skin changes.

If left untreated, these conditions can lead to high levels of pain and disability.

“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms,” said Hermine Brunner, MD, Cincinnati Children’s Hospital. “The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”

“This marks the second and third US pediatric approval this year for Cosentyx, following paediatric psoriasis approval and further reinforces the proven efficacy and safety of the therapy. With more than 500,000 adult and pediatric patients treated worldwide since launch, healthcare professionals and patients can feel confident in Cosentyx,” said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis.

“Furthermore, we are pleased to build on our strong heritage of bringing innovative treatments to young people living with rheumatic diseases, which began with the FDA approval of Ilaris. We are committed to bringing Cosentyx to this pediatric community globally as part of our ambition to expand Cosentyx to 10 indications in areas of high unmet need.”

Lina Adams

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