Regeneron Pharmaceuticals Inc. (REGN) and French drug-maker Sanofi (SNYNF, SNY) announced Friday that the U.S. Food and Drug Administration or FDA has accepted for review the Biologics License Application or BLA for sarilumab.
The target action date is October 30, 2016 per the Prescription Drug User Fee Act.
Sarilumab is 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 or 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.
The BLA for sarilumab contains data from approximately 2,500 adults with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase 3 program.
The companies noted that the goal of the ongoing global clinical development program is to evaluate the safety and efficacy of subcutaneous sarilumab, either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs, in reducing the signs and symptoms and inhibiting the radiographic progression of RA.
The safety and efficacy of sarilumab have not been fully evaluated by any regulatory authority.
For comments and feedback contact: editorial@rttnews.com
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.