Novartis’ Cosentyx has been approved by the FDA

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The FDA has given Novartis Cosentyx approval to treat enthesitis-related arthritis and psoriatic arthritis in children and adolescents.The new approvals are based on findings from the JUNIPERA study, which showed that Cosentyx® (secukinumab) reduced flare risk and improved disease activity in juvenile patients with enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) over two years1.

The safety of Cosentyx2 in these paediatric demographics was consistent with the drug’s established safety profile. The US Food and Drug Administration (FDA) approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in patients aged four and up, as well as active juvenile psoriatic arthritis (JPsA) in patients aged two and up, according to Novartis, a global leader in rheumatology and immuno-dermatology. Cosentyx is now the first and only biologic medication licensed in the United States for both ERA and PsA in paediatric patients. These are Cosentyx’s second and third paediatric approvals in the United States, giving it a total of five indications in rheumatology and dermatology1.

“Prior research suggests that despite receiving treatment, some children and adolescents with PsA or ERA can continue to experience symptoms. 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,”

said Hermine Brunner, M.D., Cincinnati Children’s Hospital. 

“This marks the second and third US pediatric approval this year for Cosentyx, following pediatric 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,”“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,”

said Todd Fox, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. 

The approval is based on results from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA based on modified International League of Associations for Rheumatology classification criteria7. The time to flare in the treatment period 2 (Week 12 to Week 104)7 was the study’s primary objective.

“The symptoms of PsA and ERA can be debilitating for children and adolescents living with these chronic conditions, impacting their daily lives. It is encouraging to see an additional treatment option for these underserved patient populations,”

said Tiffany Westrich-Robertson, CEO, International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis). 

Cosentyx was approved in the EU as a first-line systemic treatment for paediatric psoriasis in children aged 6 to 18 years old in July 2020, and it was recently approved in the US and China1,9,10. Cosentyx was licensed in Japan in 2021 to treat both PsA and psoriasis in children aged 6 and up, as well as adults with generalised pustular psoriasis11.

Novartis has made an ERA and JPsA regulatory submission for Cosentyx in Europe, with a decision significantly over the coming months.In the United States, Cosentyx is the only biologic medication licensed for both ERA (4 years of age and older) and PsA (2 years of age and older) in children and adolescents.  

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