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Tuesday, 07/19/2011 4:30:33 PM

Tuesday, July 19, 2011 4:30:33 PM

Post# of 252484
Dapagliflozin: Panel rejects AstraZeneca, Bristol diabetes pill

SILVER SPRING, Md., July 19 (Reuters) - U.S. advisers rejected a new type of diabetes pill from AstraZeneca (AZN.L) and Bristol-Myers Squibb (BMY.N) over concerns about liver and cancer risks.
A Food and Drug Administration advisory panel voted 9-6 on Tuesday against recommending approval of the drug, called dapagliflozin, for adults with Type 2 diabetes.
Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its efficacy -- especially for the elderly.
The FDA usually follows the recommendations of its advisory panels and is due to make a final decision on the drug by Oct. 28.
An estimated 200 million people across the world, and close to 26 million in the United States, have diabetes. Most have Type 2 diabetes, the kind linked to poor diet and lack of exercise.


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