The FDA has extended the action date for dapagliflozin (Bristol-Myers Squibb/AstraZeneca) for the treatment of type 2 diabetes by three months. The new Prescription Drug User Fee Act goal date is Jan. 28, 2012.
In response to an FDA request for additional data on dapagliflozin, Bristol-Myers Squibb and AstraZeneca are submitting data from recently completed and ongoing Phase 3 clinical trials. This data submission constitutes a major amendment to the original new drug application for dapagliflozin.
Dapagliflozin, an inhibitor of the SGLT2 target in the kidney, is under joint development by the companies. Dapagliflozin, as an adjunct to diet and exercise, is being investigated to evaluate its safety and its effect on blood sugar levels (glycosylated hemoglobin levels), in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents.
New York City-based Bristol-Myers Squibb and the London-based AstraZeneca entered into a collaboration in January 2007 to research, develop and commercialize select investigational drugs for type 2 diabetes.