Sanofi and Regeneron’s Kevzara (sarilumab) has been approved by the US Food and Drug Administration (FDA) to treat active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing at least 63kg.
Designated as one of the three major types of juvenile idiopathic arthritis, pJIA is a chronic disease that impacts multiple joints at a time.
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 drug is already approved in the US to treat certain adults with the inflammatory rheumatic disease polymyalgia rheumatica and moderately to severely active rheumatoid arthritis.
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.”
The approval comes less than two weeks after Sanofi and Regeneron’s Dupixent (dupilumab) was recommended by the European Medicines Agency’s human medicines committee as an add-on maintenance treatment for a subset of patients with chronic obstructive pulmonary disease (COPD).
If approved by the European Commission, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for the disease in more than a decade.