FDA Accepts Regeneron/Sanofi BLA for Arthritis

FDA has accepted a Regeneron Pharmaceuticals and Sanofi BLA for sarilumab, an investigational human monoclonal antibody that is designed to target the IL-6 receptor for treating 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 companies say. The agency has set a user fee target review date of 10/30.



The submission is supported with data from about 2,500 adults enrolled in seven studies from the companies’ SARIL-RA Phase 3 program. The studies evaluated patients with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens. They also assessed the therapy’s safety and efficacy as a monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs, including methotrexate.