FDA panel backs Bristol diabetes drug after prior rejection
By a lopsided vote of 13 to 1, an independent committee of medical experts voted on Thursday to recommend approval of a new type of diabetes drug from Bristol-Myers Squibb that U.S. regulators rejected two years ago due to safety concerns. The advisory panel to the U.S. Food and Drug Administration said the benefits of the medicine, called dapaglifozin, appear to outweigh its risks. Bristol-Myers is developing the drug, which is already approved in Europe, in partnership with AstraZeneca Plc. The FDA typically follows the advice of its advisory panels, but is under no obligation to do so. The FDA rejected the medicine in January 2012 after a previous medical advisory panel said clinical data did not provide enough certainty about its cancer and heart risks.