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Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA
Date:2/19/2013

PARIS, Feb. 19, 2013 /PRNewswire/ -- Sanofi (EURONEXT : SAN and NYSE : SNY) announced today 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.

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"We are very pleased to announce the FDA acceptance of our submission for lixisenatide in the U.S.," said Pierre Chancel, Senior Vice President, Global Diabetes at Sanofi. "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 NDA submission for lixisenatide is based on results from the GetGoal 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. 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.

The international GetGoal program included 11 clinical trials involving more than 5,000 patients with type 2 diabetes, with a large number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin (1,250 patients treated with lixisenatide or placebo in three trials).The addition of lixisenatide to basal
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