BioCentury
ARTICLE | Clinical News

Sarilumab meets Phase III RA endpoints

May 22, 2015 1:15 AM UTC

Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said sarilumab ( REGN88, SAR153191), a human mAb against the IL-6 receptor, met both co-primary efficacy endpoints in the Phase III SARIL-RA-TARGET trial to treat rheumatoid arthritis (RA). The partners intend to submit a BLA to FDA in 4Q15.

The trial compared 200 and 150 mg doses of sarilumab plus non-biologic disease modifying anti-rheumatic drugs (DMARDs) vs. placebo plus DMARDs in 546 RA patients who responded inadequately to, or were intolerant of, TNF-alpha inhibitors. ...