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FDA accepts new diabetes compound NDA

The US FDA has accepted a new drug application for dapagliflozin, an investigational type 2 diabetes compound, from AstraZeneca and Bristol-Myers Squibb

The US Food and Drug Administration (FDA) has accepted for review a new drug application (NDA) for dapagliflozin, an investigational type 2 diabetes compound, from AstraZeneca (AZ) and Bristol-Myers Squibb (BMS). The European Medicines Agency (EMA) has also validated a marketing authorisation application (MAA) for the compound. 

Both submissions include data gathered during a two-year period from a global development programme involving approximately 6,000 individuals in 40 clinical studies. To comply with FDA guidelines, the US submission also includes data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.

Dapagliflozin is designed to help control glycaemia independently of insulin pathways. It works by inhibiting sodium-glucose cotransporter-2 (SGLT2) – a specific target located in the kidney, leading to the excretion of excess glucose and associated calories in the urine.

The development of dapagliflozin is the result of a collaboration deal formed between AZ and BMS in 2007 to enable the companies to research, develop and commercialise select investigational drugs for type 2 diabetes.

According to the International Diabetes Federation (IDF), around 285 million people globally have diabetes. This figure is projected to increase to 438m by 2030.

8th March 2011

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