FDA Accepts Dapagliflozin NDA

Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA. Also, a MAA for dapagliflozin has been validated by the EMA. Both submissions were filed in December 2010. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is October 28, 2011.

The submissions included two years of data from a global development program involving approximately 6,000 individuals in 40 clinical studies. The U.S. application also includes data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.

If approved, Dapagliflozin would be the first in a new class of drugs that inhibits sodium-glucose cotransporter-2 (SGLT2), which is designed to help control glycemia independently of insulin pathways, leading to the excretion of excess glucose.
@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; }