Full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Sanofi’s Lyxumia® (lixisenatide) in adults with type 2 diabetes and high CV risk, have been presented.
As previously reported, lixisenatide met the pre-specified criterion of non-inferiority versus placebo for the composite primary endpoint of CV death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina but did not demonstrate superiority. The full results will be included in the US New Drug Application for lixisenatide, which is on track to be resubmitted to the US Food and Drug Administration in Q3 2015.
Additional safety findings include no signal for increased risk of heart failure, pancreatitis, pancreatic cancer or severe symptomatic hypoglycaemia. Lixisenatide was generally safe and well tolerated; nausea and vomiting, which are known side effects of the GLP-1 RA class, were observed more frequently with lixisenatide.
Results from the ELIXA trial will be shared with health authorities around the world
“The importance of determining the CV safety of diabetes medicines, as set out in the FDA guidance issued in 2008, is widely recognised. People around the world are being treated with GLP-1 receptor agonists, and the CV effects were unknown,” said Dr. Marc Pfeffer, Professor of Medicine at Harvard Medical School, Senior Physician in the Division of Cardiovascular Medicine at Brigham and Women’s Hospital and Chair of the ELIXA Steering Committee. “ELIXA goes beyond the FDA guidance to deliver data related to heart failure and other insights that are not currently available for any other GLP-1 receptor agonist. Our data provide the medical community, patients and caregivers with information that will better inform them about how lixisenatide can be safely used to better control their glucose.”
“As the first completed long-term CV safety study of a GLP-1 receptor agonist, the successful ELIXA trial will be shared with health authorities around the world and provides important outcomes data that can be considered by healthcare professionals,” said Pierre Chancel, Senior Vice President, Head of Global Diabetes at Sanofi. “Sanofi is committed to developing and delivering safe and effective treatment options for people with diabetes. This study supports that important work.”
