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FDA Alerts
Rheumatology

FDA approves Kevzara for treatment of active polyarticular juvenile idiopathic arthritis

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The U.S. Food and Drug Administration has approved Kevzara (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). This form of arthritis affects multiple joints simultaneously and can significantly impact the lives of affected children.

In clinical trials, the pJIA population did not exhibit any new adverse reactions or safety concerns compared to those observed in the rheumatoid arthritis population. The most frequently reported adverse reactions in pJIA patients were nasopharyngitis, neutropenia, upper respiratory tract infections, and injection site erythema. Neutropenia was the primary adverse reaction that led to the permanent discontinuation of Kevzara. Patients receiving Kevzara are at a heightened risk of developing severe infections, which may necessitate hospitalization or could be fatal.

“Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic infammation,” said George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.”

Read the full press release here.

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