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Panel rejects AstraZeneca, Bristol diabetes pill
July 19, 2011 / 8:35 PM / 6 years ago

Panel rejects AstraZeneca, Bristol diabetes pill

SILVER SPRING, Maryland (Reuters) - U.S. advisers rejected a new type of diabetes pill from AstraZeneca and Bristol-Myers Squibb 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 October 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.

Reporting by Anna Yukhananov; Editing by Gary Hill

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