PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) announced on Tuesday that the FDA had approved Kevzara, also known as sarilumab, for treating patients weighing 63 kg or more with active polyarticular juvenile idiopathic arthritis or pJIA, a type of arthritis affecting multiple joints simultaneously.
The approval is based on data from studies and pharmacokinetic information from adults with rheumatoid arthritis, along with a study on pediatric pJIA patients to determine dosage, effects, and safety.
Common adverse reactions in pJIA patients treated with Kevzara included nasopharyngitis, neutropenia, upper respiratory tract infection, and redness at the injection site.
Apart from pJIA, Kevzara is currently authorized in 25 countries for managing moderately to severely active rheumatoid arthritis.
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