Sanofi announces cardiovascular study results of Lyxumia

Sanofi announced results of the phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety.


Dr Elias Zerhouni, president, global R&D, Sanofi

The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety.

ELIXA full results will be presented on Monday, June 8, 2015, at the American Diabetes Association 75th Scientific Sessions in Boston by the ELIXA steering committee, chaired by Dr Marc Pfeffer.

The results will also be included in the US New Drug Application of lixisenatide, which is on track to be resubmitted to the US Food and Drug Administration (USFDA) in the third-quarter of 2015.

Lixisenatide is not approved in the United States.

"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," said Dr Elias Zerhouni, president, global R&D, Sanofi. "Sanofi looks forward to submitting the results to health authorities worldwide."

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