FDA Accepts Sanofi’s BLA for Rheumatoid Arthritis

Sanofi and Regeneron Pharmaceuticals, Inc., a biopharmaceutical company, report that the US Food and Drug Administration (FDA) has accepted for review the biologics license application (BLA) for sarilumab, an investigational, human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA and levels correlate with both disease activity and joint destruction.

Per the Prescription Drug User Fee Act (PDUFA), the target action date for FDA Review is October 30, 2016.

Source: Sanofi

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