FDA to review Sanofi and Regeneron Biologics License Application for sarilumab

Sanofi and Regeneron Pharmaceuticals Inc. announced last week that the U.S. Food and Drug Administration (FDA) will review their Biologics License Application for sarilumab, an antibody that will help treat patients with moderate-to-severe rheumatoid arthritis.

Sarilumab targets the IL-6 receptor, which is a cytokine. Cytokines are small proteins important in cell signaling. They are released by cells and affect the behavior of other cells. IL-6 Is the most abundant cytokine in the serum and synovial fluid of patients with rheumatoid arthritis. The levels of IL-6 directly corresponds with disease activity and joint deterioration. The goal of sarilumab is to inhibit the IL-6 receptor from enabling the disease.

The Biologics License Application for sarilumab contains data from more than 2,500 adults with active, moderate-to-severe rheumatoid arthritis who had a negative reaction to prior treatments. The FDA will decide if sarilumab is safe and effective either as a single prescription to combat rheumatoid arthritis or in combination with other anti-rheumatic drugs.

Sanofi is a global leader in therapeutic solutions to patients’ needs and Regeneron Pharmaceuticals is a science-based biopharmaceutical company that develops medicines for the treatment of serious medical conditions.

The target date for sarilumab is Oct. 30.