FDA Accepts Sanofi’s NDA for New Diabetes DrugBy
The US 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 treating adults with Type 2 diabetes mellitus.
Lixisenatide was in-licensed from Zealand Pharma A/S and was approved in Europe in 2013 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 currently approved in over 60 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. 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.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for treating adult 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.