FDA to Review BLA Resubmission of Rheumatoid Arthritis Biologic
Regeneron and Sanofi announced that the Food and Drug Administration has accepted for review the resubmission of the Biologics License Application (BLA) for Kevzara (sarilumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
The BLA resubmission acceptance was a Class I response with a two month review timeline. The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2017 for a decision on the BLA.
Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor.