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5 Aug 2013

FDA Acknowledg?es Receipt of Resubmissi?on of the New Drug Applicatio?n for Investigat?ional Compound Dapagliflo?zin

AstraZeneca and Bristol-Myers Squibb Company have announced that FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of 11 January 2014.

The dapagliflozin Phase II/III clinical development programme included more than 12,000 adult patients with diabetes (more than 8000 patients received dapagliflozin) in 26 clinical trials. In response to FDA’s January 2012 complete response letter requesting additional data to allow a better assessment of the benefit-risk profile of dapagliflozin, the NDA resubmission includes several new studies and additional long-term data (up to 4 years’ duration) from previously submitted studies, resulting in an overall increase in patient-years exposure to dapagliflozin of more than 50%.

Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. It is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand.

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