The condition causes joint pain, stiffness and swelling, which can lead to an increased risk of permanent joint damage as well as delayed growth and development.
IL-6, an immune system protein produced in increased quantities in patients with rheumatoid arthritis, has been associated with disease activity, joint destruction and other systemic problems.
Kevzara, which is being jointly developed by Sanofi and Regeneron under a global collaboration agreement, binds specifically to the IL-6 receptor and has been shown to inhibit IL-6-mediated signalling.
The FDA’s latest decision was supported by evidence from “adequate and well-controlled studies” and pharmacokinetic data from adults with rheumatoid arthritis, as well as a pharmacokinetic, pharmacodynamic, dose-finding and safety study in paediatric patients with pJIA, the companies outlined.
No new adverse reactions or safety concerns were identified in the pJIA population compared to the rheumatoid arthritis population.
Brian Foard, executive vice president, head, specialty care at Sanofi, said: “This latest approval for Kevzara brings a new treatment option with an established efficacy and safety profile to paediatric patients living with pJIA.”
Also commenting on the authorisation, George Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, said: “Not only are [pJIA patients’] daily lives impacted, but their futures can be disrupted without adequate treatment.
“The approval of Kevzara in pJIA provides these vulnerable patients and their families [with] a new FDA-approved treatment option to help navigate this disease.”
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