Sanofi announces top-line results for cardiovascular outcomes study of Lyxumia® (lixisenatide)
Sanofi has today announced top-line 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.
The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety.
ELIXA(Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With Lixisenatide) full results will be presented 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 in the third-quarter of 2015. Lixisenatide is not approved in the United States.
Dr Elias Zerhouni, President, Global R&D 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. Sanofi looks forward to submitting the results to health authorities worldwide.”
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 cardiovascular risk, comparing lixisenatide to placebo in a high-risk population of adults with Type 2 diabetes.
More than 6,000 adults with Type 2 diabetes and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event) participated in the trial. The composite primary endpoint, which was evaluated for non-inferiority and superiority, comprised cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina. The global ELIXA study started in June 2010 and was completed in 2015.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult people 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 stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control 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.
Lixisenatide is currently approved in over 50 countries worldwide for the treatment of adults with Type 2 diabetes, with commercial launches in some European countries, Japan, Brazil, Mexico and other markets. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide. The proprietary name in the U.S. is under consideration.