FDA Agrees to Review Diabetes Drug Lixisenatide
Agency submission follows drug’s approval in Europe (Feb. 19)
The FDA has accepted for review a new drug application (NDA) for lixisenatide (Sanofi), a once-daily prandial glucagon-like peptide-1(GLP-1) receptor agonist for the treatment of adults with type 2 diabetes mellitus. The acceptance of the lixisenatide NDA filing follows the February 1 approval of lixisenatide in the E.U.
The NDA submission for lixisenatide was based on results from the GetGoal clinical trial program, in which lixisenatide significantly reduced hemoglobin A1c (HbA1c), lowered post-prandial glucose (PPG), and had a beneficial effect on body weight in adult patients with type 2 diabetes. Lixisenatide also had a favorable safety and tolerability profile in most patients, with mild and transient nausea and vomiting (the most common adverse events observed in the GLP-1 receptor agonist class) and a limited risk of hypoglycemia.
The GetGoal program included 11 clinical trials involving more than 5,000 patients with type 2 diabetes who were treated with a GLP-1 receptor agonist in combination with basal insulin. A total of 1,250 patients received 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 was shown to have a pronounced PPG-lowering effect, which appears to complement the predominantly fasting plasma glucose (FPG)-lowering effect of basal insulin. For patients treated with basal insulin who have controlled FPG but who are no longer able to achieve their HbA1c goal because of the progression of type 2 diabetes, adding lixisenatide, which targets PPG, could be an effective strategy to achieve target glucose control, according to Sanofi, the drug’s developer.
Lixisenatide is a GLP-1 receptor agonist. 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 to stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Source: Sanofi; February 19, 2013.