Sanofi said it will resubmit lixisenatide, its once-daily treatment for type 2 diabetes patients, to the FDA in the third quarter.
The drugmaker announced its plans to resubmit the GLP-1 receptor agonist during the American Diabetes Association’s Scientific Sessions conference in Boston.
The Phase-IIIb study—dubbed Elixa— found no difference in likelihood of heart attack and stroke in patients taking lixisenatide and those taking the placebo. The Elixa trial is the first outcomes study for the GLP-1 receptor agonist class of diabetes drugs, which includes Novo Nordisk’s Victoza, AstraZeneca’s Byetta/Bydureon and Eli Lilly’s Trulicity. GLP-1’s are considered an add-on treatment for people with type 2 diabetes.
Sanofi originally submitted lixisenatide to the FDA in 2013 but pulled the application after the FDA requested an interim analysis of its cardiovascular outcomes study. The FDA took a stronger stance toward the cardiovascular safety of diabetes drugs in 2008 after GlaxoSmithKline’s Avandia was linked to heart attacks.
An earlier version of the story incorrectly identified lixisenatide by its ex-US proprietary name and that it belonged to the insulin class of diabetes treatments. It is a GLP-1 receptor agonist.