FDA panel backs dapagliflozin
FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 that the benefit-risk profile of dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) supported approval as an adjunct to diet and exercise to treat Type II diabetes. The panel also voted 10-4 that the pharma had demonstrated an acceptable cardiovascular risk profile for the sodium-glucose cotransporter 2 (SGLT2) inhibitor.
The vote was an about-face from a 2011 panel meeting in which members voted 9-6 against approval of dapagliflozin due to concerns about the risks of bladder and breast cancer as well as hepatotoxicity. Four of the panel members from the 2011 meeting were present at Thursday's meeting and backed dapagliflozin, including three who had previously voted no. ...