Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

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The FINANCIAL — Sanofi announced on September 29 that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus (T2DM).

“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 U.S.”

The NDA submission for lixisenatide is based on results from the GetGoal clinical program1,2 and includes findings from the recently-completed ELIXA study,3 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), according to Sanofi.

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


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