Sanofi files lixisenatide at FDA for treatment of Type 2 Diabetes

The FDA has accepted for review a New Drug Application (NDA) for lixisenatide from Sanofi, the first once-daily prandial 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, 2013, European Commission approval of lixisenatide as Lyxumia, in the European Union.

The NDA submission for lixisenatide is based on results from the GET GOAL clinical program, which showed that lixisenatide demonstrated 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.

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.