This is interesting, perhaps even exciting because it represents an innovative way to manage diabetes independent of insulin (press release emailed to me this AM):
Bristol-Myers today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus. A Marketing Authorisation Application (MAA) for dapagliflozin has also been validated by the European Medicines Agency (EMA). The NDA and MAA submissions for dapagliflozin were filed in December 2010. The Prescription Drug User Fee Act (PDUFA) goal
date for the FDA is October 28, 2011.
The U.S. and European submissions included data of up to two years in duration from a global development program involving approximately 6,000 individuals in 40 clinical studies. In accordance with FDA guidelines, the U.S. application also includes data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.
If approved, dapagliflozin would potentially be the first in a class of novel agents for diabetes that inhibit sodium-glucose cotransporter-2 (SGLT2), a specific target located in the kidney. Through this mechanism, dapagliflozin is designed to help control glycemia independently of insulin pathways, leading to the excretion of excess glucose and associated calories in the urine.
How does it work?
The renal SGLT system plays a major role in overall glucose balance in the body. Normally, the kidney filters ~180g of glucose each day, and virtually all is reabsorbed back into circulation. Glucose reabsorption occurs in the proximal tubule of the kidney via the SGLT system. Selective inhibition of SGLT2 by an insulin independent mechanism of action is designed to lead to the excretion of excess glucose and associated calories in the urine, thereby lowering blood glucose levels.
I’ll research and update later. Comments?