FDA Approves Novartis’ Cosentyx to Treat Arthritis in Children and Adolescents

Novartis has received U.S. Food and Drug Administration (FDA) approval for its Cosentyx (secukinumab) to treat children and adolescents with enthesitis-related arthritis and psoriatic arthritis. The human biologic was developed to directly target interleukin-17A, a cytokine involved in the inflammation of plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis, moderate to severe plaque psoriasis and nonradiographic axial spondyloarthritis.

Cosentyx is indicated to treat active enthesitis-related arthritis (ERA) in individuals aged 4 years and above, and active juvenile psoriatic arthritis (JPsA) in patients aged 2 years and above. It is the only biologic treatment approved for pediatric patients for both ERA and JPsA in the U.S. The approved pediatric dosing of Cosentyx is 75 mg (15 kg or more to less than 50 kg) or 150 mg (50 kg or more) injection, administered every four weeks for children and adolescents.

“This marks the second and third U.S. pediatric approval this year for Cosentyx, following pediatric psoriasis approval, and further reinforces the proven efficacy and safety of the therapy,” said Todd Fox, Novartis’ medical affairs immunology, hepatology and dermatology global head. “With more than 500,000 adult and pediatric patients treated worldwide since launch, healthcare professionals and patients can feel confident in Cosentyx.”