Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) announced on Tuesday that the FDA has approved Kevzara, also known as sarilumab, for the treatment of patients weighing 63 kg or more with active polyarticular juvenile idiopathic arthritis (pJIA), a condition characterized by multiple joint inflammation.
This approval was granted based on data collected from adult rheumatoid arthritis studies and pharmacokinetic information, as well as a dedicated study on pediatric pJIA patients to establish appropriate dosage, effectiveness, and safety profiles.
The most common adverse reactions observed in pJIA patients treated with Kevzara included nasopharyngitis, neutropenia, upper respiratory tract infections, and injection site erythema.
In addition to its newly approved use for pJIA, Kevzara is already authorized in 25 countries for the treatment of moderately to severely active rheumatoid arthritis.
