Sanofi on track to resubmit NDA for lixisenatide

Sanofi (Euronext:SAN; NYSE:SNY) said it now plans to resubmit an NDA for lixisenatide to FDA in 3Q15 after releasing data showing the compound was non-inferior, but not superior, to placebo for cardiovascular safety in the Phase IIIb ELIXA CV outcomes study in high-risk patients with Type II diabetes.

The 6,000-patient study had a composite primary endpoint evaluating both non-inferiority and superiority vs. placebo. The pharma will present full results at the American Diabetes Association meeting in Boston on June 8. ...