Panel rejects AstraZeneca, Bristol diabetes pill
SILVER SPRING, Maryland |
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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