March 08, 2011
Bristol-Myers Squibb, AstraZeneca's application for diabetes drug dapagliflozin accepted by FDA, EMA
AstraZeneca and Bristol-Myers Squibb announced Tuesday that the FDA and EMA accepted the companies' marketing applications for dapagliflozin for the treatment of adults with type 2 diabetes. If approved, dapagliflozin "would potentially be the first in a class of novel agents" for patients with the disease, according to the drugmakers.
The filing includes data from a global development programme involving approximately 40 studies that enrolled 6000 patients. The FDA application also includes data on the cardiovascular safety of the drug in the proposed patient population in accordance with current agency guidelines.
The companies said that dapagliflozin is designed to inhibit sodium-glucose cotransporter-2 a target located in the kidney, that allows glycaemic control to be achieved independently of insulin pathways and allows for the excretion of excess glucose in the urine.