FDA acknowledges receipt of resubmission of the new drug
application for investigational compound dapagliflozin for the
treatment of type 2 diabetes
Friday, 26 July 2013
AstraZeneca and Bristol-Myers Squibb Company today announced that the
U.S. Food and Drug Administration (FDA) has acknowledged receipt of the
New Drug Application (NDA) resubmission for investigational drug
dapagliflozin 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 European Union, Australia, Brazil,
Mexico and New Zealand.
Scancomark.com Team