Currently Viewing:
Newsroom
Currently Reading
ELIXA Results on Lixisenatide Published in NEJM
December 03, 2015 – Mary K. Caffrey
Under Pressure, Coca-Cola Backed Research Group Fizzles
December 02, 2015 – AJMC Staff
After Several Clues, CDC Confirms Drop in New Diabetes Cases
December 01, 2015 – Mary K. Caffrey
Pharmaceutical Advertising Increased Prescription Drug Utilization, Study Reports
November 30, 2015 – Surabhi Dangi-Garimella, PhD
Testosterone Therapy Could Help Men With Type 2 Diabetes
November 30, 2015 – AJMC Staff
Top 5 Diabetes Stories for the Year
November 27, 2015
American College of Physicians Recommends More Use of Generic Medications
November 27, 2015 – Surabhi Dangi-Garimella, PhD
Mississippi to Pay for Bariatric Surgery to Combat Obesity
November 25, 2015 – Mary K. Caffrey
What We're Reading: Coke Interfered With Work of Anti-Obesity Group
November 25, 2015 – AJMC Staff

ELIXA Results on Lixisenatide Published in NEJM

Mary K. Caffrey
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.

Reference

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.

 
Copyright AJMC 2006-2019 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up