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Sanofi will resubmit Lyxumia for FDA approval in Q3

Follows the GLP-1 agonist's all-clear by ELIXA cardiovascular safety study

Sanofi's Lyxumia packshot  

The first cardiovascular safety study of a GLP-1 agonist has found no evidence of cardiac risk, hypoglycaemia risk or pancreatic injury.

The ELIXA trial of Sanofi's Lyxumia (lixisenatide) was one of two standout safety trials - alongside the TECOS study of Merck & Co's Januvia (sitagliptin) - reported this week at the American Diabetes Association's Scientific Sessions in Boston.

It found no increased risk for cardiovascular death, heart attack, stroke, unstable angina or heart failure and trial investigators said they saw a modest weight control benefit of 0.7kg less in Lyxumia patients.

Although the 'Evaluation of Lixisenatide in Acute Coronary Syndrome' (ELIXA) trial failed to meet its original primary objective of demonstrating a reduction in cardiovascular morbidity and mortality, the results are still a significant milestone in Sanofi's diabetes efforts.

They pave the way for the company to resubmit Lyxumia for approval in the US, something the company expects to happen by September. 

In 2013 the FDA's request for an interim analysis of the study prompted Sanofi to pull Lyxumia's US approval submission until it could present the regulator with fuller findings from ELIXA.

The type 2 diabetes study ran for three years, with a two-year follow-up, and involved more than 6,000 people who had recently experienced acute coronary syndrome events and were therefore at high risk for additional heart problems.

Patients in the randomised, double-blind, placebo-controlled were on a variety of widely used treatment regimens, with 39% on insulin, and half received Lyxumia and half placebo.

Principal investigator for ELIXA Marc Pfeffer from Harvard Medical and Brigham and Women's Hospital told reporters the results were neutral - “we did not improve and we can claim safety within the FDA definition of safety”.

He added: “Our conclusion in these high-risk patients is that we're safe, from a cardiovascular point of view … and this should provide physicians and patients reassurance for this adjunctive therapy to better control their glucose status.”

The study findings have yet to be published, but will be submitted as a manuscript to a medical journal.

Article by
Dominic Tyer

9th June 2015

From: Research



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