AstraZeneca/Bristol-Myers diabetes drug dapagliflozin NDA accepted by US FDA

The US Food and Drug Administration has accepted for review a New Drug Application for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus, being developed by Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb (NYSE: BMY).

Additionally, the companies said, a Marketing Authorization Application for dapagliflozin has also been validated by the European Medicines Agency. The NDA and MAA submissions for dapagliflozin were filed in December 2010. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is October 28, 2011.

The US and European submissions included data of up to two years in duration from a global development programme involving approximately 6,000 individuals in 40 clinical studies. In accordance with FDA guidelines, the US application also includes data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.