FDA accepts BLA for sarilumab as a treatment for RA with PDUFA date for 30 October 2016- Regeneron + Sanofi.

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the FDA has accepted for review the Biologics License Application (BLA) for sarilumab. Per the Prescription Drug User Fee Act (PDUFA), the target action date is Oct. 30, 2016. 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 (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 III program. 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 (DMARDs), including methotrexate (MTX), 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.

Comment:The treatment is in the same class as Roche's Actemra/RoActemra (tocilizumab) also an interleukin 6 receptor inhibitor. There will be also a need to distinguish sarilumab from sirukumab, another fully human anti IL 6R antibody from GSK, possibly by showing superiority in patient subgroups or lower cost. The drug is likely to be positioned for those who fail in disease modifying anti rheumatic drugs (DMARDs) and anti TNF agents.