Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA).
The BLA submission is based on data from the ongoing global clinical development program for sarilumab including 7 Phase 3 studies from the SARIL-RA program and approximately 2500 adults with active, moderate-to-severe RA who had an inadequate response to previous therapies. The clinical program aims to evaluate the efficacy and safety of sarilumab either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX), in reducing the signs and symptoms and inhibiting the radiographic progression of RA.
The FDA has set a target action date of October 30, 2016 per the Prescription Drug User Fee Act (PDUFA).
Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor.