Sanofi, Regeneron submit FDA application for sarilumab for treatment of RA

Sanofi and Regeneron Pharmaceuticals Inc. announced the FDA has accepted its Biologics License Application for sarilumab for the treatment of active, moderate-to-severe rheumatoid arthritis, according to a press release.

Data from studies of sarilumab, including seven phase 3 studies on 2,500 patients with rheumatoid arthritis, were submitted with the application. Sarilumab is a subcutaneous treatment and targets the interleukin-6 receptor present in the serum and synovial fluid of patients with rheumatoid arthritis. Ongoing clinical development of sarilumab is designed to evaluate the safety and efficacy of the biologic either as monotherapy or in combination with methotrexate or other conventional disease-modifying anti-rheumatic drugs.

The target action date is Oct. 30, 2016 based on provisions in the Prescription Drug User Fee Act.

Reference:

http://en.sanofi.com