Sanofi reports positive data from Lyxumia cardiovascular safety trial

Sanofi has announced positive top-line results of the phase IIIb ELIXA cardiovascular outcomes study, which evaluated the safety of its diabetes drug Lyxumia.

The trial compared Lyxumia to placebo in a high-risk population of adults with type 2 diabetes, finding that Sanofi's drug was non-inferior, although not superior, to placebo for cardiovascular safety.

Involving more than 6,000 patients, the ELIXA study lasted for five years and was the first event-driven cardiovascular outcomes study to provide data for a glucagon-like peptide-1 receptor agonist.

Data from this trial will be presented at the forthcoming American Diabetes Association Scientific Sessions and will support Sanofi's efforts to secure US regulatory approval for the drug.

Dr Elias Zerhouni, president for global research and development at Sanofi, said: "The completion of the ELIXA study is a significant milestone for lixisenatide, which is the first GLP-1 receptor agonist with long-term cardiovascular safety data in people with diabetes who have high cardiovascular risk."

This comes after the company recently received a recommendation from the Committee for Medicinal Products for Human Use for European approval of its new diabetes drug Toujeo.