European Medicines Agency accepts review of Marketing Authorization Application for sarilumab

Sanofi and Regeneron Pharmaceuticals Inc. announced the European Medicines Agency has agreed to review the Marketing Authorization Application for sarilumab, a human monoclonal antibody targeting the interleukin-6 receptor. The treatment is intended for adult patients with moderate to severe rheumatoid arthritis.

According to the release, the Marketing Authorization Application for sarilumab was based on seven phase 3 trials that were part of the SARIL-RA clinical development program. The goal of the program was to evaluate the safety and efficacy of sarilumab used as monotherapy or in combination with conventional disease-modifying antirheumatic drugs to reduce the signs and symptoms of rheumatoid arthritis, to inhibit radiographic progression of the condition and to improve physical function.

In the first quarter of 2016, a biologics license application for sarilumab was accepted by the FDA. According to the Prescription Drug User Fee Act, the target action date is Oct. 30, 2016.

Reference:

http://en.sanofi.com/