The FDA has accepted for review Sanofi and Regeneron Pharmaceuticals' biologics license application for sarilumab.
The FDA has accepted for review Sanofi and Regeneron Pharmaceuticals’ biologics license application for sarilumab.
This investigational, human monoclonal antibody targets the IL-6 receptor to treat moderate-to-severe rheumatoid arthritis.
The application submitted for review to the FDA includes data involving around 2500 adults with moderate-to-severe rheumatoid arthritis who did not respond well to previous treatment regimens.
The data spans 7 studies from the SARIL-RA phase 3 program.
Ongoing clinical programs are testing sarilumab for its safety and efficacy either by itself or in combination with disease-modifying anti-rheumatic drugs including methotrexate.
Sanofi and Regeneron last presented information from the SARIL-RA phase 3 studies back in November 2015. Data showed that the product could significantly improve the signs, symptoms, and physical function of patients with rheumatoid arthritis.
"Rheumatoid arthritis can be a debilitating disease that has a significant impact on a patient, and despite the availability of a wide range of treatments, new agents are still needed to address unmet patient needs including failure to respond to therapy," said lead study author Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center, in a press release. "These data suggest that sarilumab, if approved, may be a potential option for patients with moderate-to-severe RA [rheumatoid arthritis]."
The target action date set is October 30, 2016.