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Zealand Pharma A/S' Partner Sanofi SA Announces New Drug Application for Lixisenatide in United States for Review


Tuesday, 19 Feb 2013 04:40am EST 

Zealand Pharma A/S announced that its partner Sanofi announced that the United States Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for lixisenatide as the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with Type 2 diabetes. The NDA for lixisenatide is based on results from the GetGoal clinical Phase III program, which showed that treatment with lixisenatide gave 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 common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycemia. The addition of lixisenatide to basal insulin was studied because these medicines target separate components of HbA1c, an important measure of longer term blood glucose control. Lixisenatide has a pronounced PPG-lowering effect, which complements the predominantly fasting plasma glucose (FPG)-lowering effect of basal insulin. For patients treated with basal insulin who have controlled FPG but who, due to the progression of Type 2 diabetes, are no longer able to achieve their HbA1c goal, adding lixisenatide could be an effective treatment strategy to achieve better glucose control. 

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