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Positive Results Reported From Cardiovascular Outcomes Study of Lixisenatide

Findings support resubmission of NDA

Positive results have been reported from a phase IIIb study that evaluated the cardiovascular safety of lixisenatide (Sanofi) compared with that of placebo in a high-risk population of adults with type-2 diabetes. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety.

Full results from the ELIXA (Evaluation of LIXisenatide in Acute Coronary Syndrome) trial will be presented June 8 at the American Diabetes Association’s 75th Scientific Sessions in Boston, Massachusetts. The results will also be included in the new drug application (NDA) for lixisenatide, which is on track to be resubmitted to the FDA in the third quarter of 2015. Lixisenatide is not approved for use in the U.S.

According to Sanofi, ELIXA is the first event-driven cardiovascular outcomes study to provide data for a glucagon-like peptide-1 receptor agonist (GLP-1 RA).

ELIXA was a randomized, double-blind, parallel-group trial designed to evaluate the cardiovascular risk of lixisenatide compared with that of placebo in more than 6,000 adults with type-2 diabetes and high cardiovascular risk (i.e., patients who had recently experienced a spontaneous acute coronary-syndrome event). The composite primary endpoint, which was evaluated for non-inferiority and superiority, comprised cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina. The study started in June 2010 and was completed in early 2015.

Lixisenatide is a once-daily prandial GLP-1 RA for the treatment of adults with type-2 diabetes mellitus. GLP-1 is a naturally occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and to stimulate glucose-dependent insulin secretion by pancreatic beta cells.

In September 2013, Sanofi decided to withdraw its NDA for lixisenatide, which included early interim results from the ongoing ELIXA study. The decision to withdraw the lixisenatide application followed discussions with the FDA regarding its proposed process for the review of interim data.

Lixisenatide is currently approved in more than 50 countries worldwide for the treatment of adults with type-2 diabetes. In Europe, the drug is used in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

The drug’s proprietary name in the U.S. is under consideration.

Source: Sanofi; March 19, 2015; and Sanofi; September 17, 2013.


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