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FDA Accepts Sanofi SA's New Drug Application for Lixisenatide for Review


Tuesday, 19 Feb 2013 01:00am EST 

Sanofi SA announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for lixisenatide, 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 in the European Union. The NDA submission for lixisenatide is based on results from the GetGoal clinical program, which showed that lixisenatide demonstrated 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. GetGoal results also showed that lixisenatide 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. Sanofi is preparing to launch lixisenatide in the European Union as of late Q1 2013 under the name Lyxumia. The proprietary name for lixisenatide in the United States is under consideration. 

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