FDA panel backs Bristol diabetes drug after prior rejection
Dec 12 (Reuters) - By a lopsided vote of 13 to 1, an independent committee of medical experts on Thursday voted 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 on Thursday 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.
In another vote, of 10 to 4, the panel found the drug appeared to have a favorable cardiovascular safety profile.