The US Food and Drug Administration (FDA) has accepted to review Sanofi's new drug application (NDA) of lixisenatide, a once-daily a glucagon-like peptide-1 receptor agonist (GLP-1 RA), for the treatment of adults with type 2 diabetes mellitus.
The acceptance of the lixisenatide NDA filing follows the 1 February 2013 European Commission approval of lixisenatide in the European Union (EU), according to Sanofi.
The application for lixisenatide included results from the GetGoal clinical program, which 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.
In addition, GetGoal results demonstrated that lixisenatide had a favorable safety and tolerability profile in patients with mild and transient nausea and vomiting, and a limited risk of hypoglycemia.
NDA also included data from the ongoing ELIXA trial, a cardiovascular outcome (CV) study of lixisenatide in patients at high CV risk.
Sanofi global diabetes senior vice president Pierre Chancel said, "This important milestone is the result of our company's continuing worldwide effort to meet the needs of people living with diabetes, and we look forward to working with the FDA during the review process."
The company, which is preparing to launch lixisenatide, under the proprietary name Lyxumia, in the EU in Q1 2013, said the proprietary name for lixisenatide in the US is under consideration.
