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

insulin was studied because these medicines target separate components of HbA1c, an important measure of 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, which targets PPG, could be an effective strategy to achieve target glucose control.

Available data from the ongoing ELIXA trial, a cardiovascular outcome (CV) study of lixisenatide in patients at high CV risk (i.e. patients who recently experienced an acute coronary event) were also submitted, as required by the FDA.

Sanofi is preparing to launch lixisenatide in the European Union as of late Q1 2013, under the proprietary name Lyxumia. The proprietary name for lixisenatide in the United States is under consideration.

About lixisenatide
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is also approved in Mexico for th
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