Results first presented at the American Diabetes Association in June are published. The new drug application has since been filed at FDA.
Results from the ELIXA trial, which showed that the GLP-1 receptor agonist lixisenatide did not have any adverse cardiac effects, have been published in the New England Journal of Medicine.
The Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) results were first presented in June at the 75th Scientific Sessions of the American Diabetes Association in Boston. Since then, FDA has accepted Sanofi’s new drug application for the diabetes therapy, which is sold as Lyxumia in Europe.
ELIXA is among the cardiovascular outcomes trials now required by FDA to ensure that new diabetes therapies do not present increased risks. Often, these trials occur or continue after a drug has received a limited indication, as is the case with the 2 recent approvals for PCSK9 inhibitors to lower low-density lipoprotein cholesterol.
In this case, Sanofi initially submitted an application in 2013 but pulled it after regulators asked for interim cardiovascular data. Thus, lixisenatide will go through the process with all that data available.
ELIXA randomized 6068 patients for a median of 25 months. All had type 2 diabetes and had recently had a heart attack or been hospitalized for unstable angina. They were randomized for lixisenatide, a glucagon-like peptide receptor agonist (GLP-1), or placebo. A primary end-point event occurred in 406 patients (13.4%) of the lixisenatide group and 399 (13.2%) of the placebo group, which showed the study drug did pose any greater risk but also did not provide any cardiovascular benefit.
Sanofi is developing lixisenatide for use as a monotherapy and in combination with its mainstay insulin, Lantus.
Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23):2247-2257.