AstraZeneca and Bristol-Myers Squibb Resubmit New Type 2 Diabetes Treatment for FDA Approval

AstraZeneca and Bristol-Myers Squibb Company resubmitted a New Drug Application (NDA) to the U.S. FDA for the investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan. 11, 2014.

Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. SGLT2, a sodium-glucose cotransporter found predominantly in the kidney, is responsible for approximately 90 percent of glucose reabsorption. In patients with type 2 diabetes, the capacity of the kidney to reabsorb glucose is increased by approximately 20 percent, further exacerbating the hyperglycemia associated with the disease. Dapagliflozin selectively inhibits SGLT2 and as a result promotes the loss of glucose in the urine, lowering blood glucose levels.

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. The dapagliflozin Phase 2/3 clinical development program included more than 12,000 adult patients with diabetes (more than 8,000 patients received dapagliflozin) in 26 clinical trials.

Dapagliflozin is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand.

In March, 2013, the FDA approved Janssen’s SGLT2 inhibitor, Invokana, for treatment of adult type 2 diabetes patients.