Sanofi NDA for lixisenatide accepted for review by FDA

First New Drug Application for a GLP-1 receptor agonist to include CV outcomes data.

"The FDA filing notification for lixisenatide is an important milestone for Sanofi," said Pierre Chancel, Senior Vice President, Head of Global Diabetes at Sanofi. "Sanofi's integrated portfolio of marketed products provides treatment, monitoring and support at every stage of the diabetes journey. Lixisenatide is a critical element of this portfolio, and we look forward to working with the FDA during the review process with the goal of bringing lixisenatide to patients in the US."

The NDA submission for lixisenatide is based on results from the GetGoal clinical program and includes findings from the recently-completed ELIXA study, the first completed long-term CV outcomes study of a GLP-1 receptor agonist. The GetGoal Phase III clinical program enrolled more than 5,000 patients worldwide, evaluating the safety and efficacy of lixisenatide, including its treatment effect on HbA1c, post-prandial glucose and body weight in adults with T2DM. The ELIXA trial evaluated the cardiovascular safety of lixisenatide versus standard of care in more than 6,000 adults with T2DM and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event).

The proprietary name for lixisenatide in the US is under consideration. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities.