The Associated Press October 26, 2011, 4:53PM ET

FDA delays ruling on Bristol-Myers diabetes drug

Bristol-Myers Squibb Co. and AstraZeneca PLC said Wednesday that U.S. regulators will take three more months to review an experimental diabetes pill the companies want it to approve, delaying a decision on the drug to late January.

The companies expected the Food and Drug Administration to make a decision on the drug, called dapagliflozin, on Friday, but the agency will now make a decision by Jan. 28. The companies said the FDA asked for more information on dapagliflozin, which is a once-per-day pill that is designed to help diabetes patients eliminate excess sugar through their urine. Bristol-Myers and AstraZeneca submitted additional data from late-stage clinical trials of the drug, and the FDA will use the next three months to review that data.

Dapagliflozin is intended as a treatment for type 2 diabetes. In July, an FDA advisory panel said the drug should not be approved because of potential safety hazards. Elevated rates of bladder and breast cancer were reported in clinical trials, and panelists were also concerned about infections and possible liver damage.

Bristol-Myers Squibb is based in New York. Its shares rose 40 cents to close at $32.51 as the market moved higher on Wednesday. Shares of London-based AstraZeneca rose 98 cents, or 2.1 percent, to $48.81. In aftermarket trading its shares fell 38 cents to $32.13.


BW Mall - Sponsored Links

Buy a link now!