26 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The US FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin from AstraZeneca and Bristol-Myers Squibb (BMS) for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act goal date of January 11 2014.
The dapagliflozin phase II/III clinical development program included more than 12,000 adult patients with diabetes (more than 8,000 patients received dapagliflozin) in 26 clinical trials.
In response to the 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 four years' duration) from previously submitted studies, resulting in an overall increase in patient-years exposure to dapagliflozin of more than 50 percent.
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 EU, Australia, Brazil, Mexico and New Zealand.