FDA Accepted Sanofi's New Drug Application for Lixisenatide for Review
Sanofi announced that the FDA has accepted for review a New Drug Application (NDA) for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus. Lixisentatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) which suppresses glucagon secretion from pancreatic alpha cells and stimulates glucose-dependent insulin secretion by pancreatic beta cells.
The NDA submission is based on results from the GetGoal clinical program, which demonstrated that lixisenatide showed significant reductions in HbA1C, a pronounced post-prandial glucose (PPG)-lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes.
The international GetGoal program included 11 clinical trials involving more than 5,000 patients with type 2 diabetes, with a large number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin (1,250 patients treated with lixisenatide or placebo in three trials).The addition of lixisenatide to basal insulin was studied because these medicines target separate components of HbA1c, an important measure of blood glucose control. Lixisenatide has a pronounced PPG-lowering effect, which complements the predominantly fasting plasma glucose (FPG)-lowering effect of basal insulin. For patients treated with basal insulin who have controlled FPG but who, due to the progression of type 2 diabetes, are no longer able to achieve their HbA1c goal, adding lixisenatide, which targets PPG, could be an effective strategy to achieve target glucose control. Available data from the ongoing ELIXA trial, a cardiovascular outcome (CV) study of lixisenatide in patients at high CV risk (i.e. patients who recently experienced an acute coronary event) were also submitted, as required by the FDA.For more information call (800) 446-6267 visit http://www.sanofi-aventis.us