Posted by Michael Wonder on 01 Aug 2016
EMA to review marketing authorisation application for sarilumab
1 August 2016 - Sanofi and Regeneron Pharmaceuticals have announced the EMA has accepted for review the marketing authorisation application for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
The marketing authorisation application for sarilumab is primarily based on results from seven Phase 3 trials in the global SARIL-RA clinical development programme, which incorporate data from more than 3,300 adults.
A biologics license application for sarilumab was accepted for review by the U.S. FDA in the first quarter of 2016. The target action date is 30 October 2016.
