FDA Staff Cautious On AstraZeneca PLC, Bristol-Myers Squibb Company Diabetes Drug

Published: Dec 10, 2013

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U.S. Food and Drug Administration staff said on Tuesday they were wary about the benefits versus the risks of AstraZeneca and Bristol-Myers Squibb's new diabetes drug dapagliflozin. In documents posted on the agency's website ahead of an advisory committee meeting on Thursday, staff said the latest evidence was mixed in terms of the drug's heart benefits and the possible risk of bladder cancer or liver damage. "As a result of these updated analyses the agency could not conclude with any level of confidence that the purported CV (cardiovascular) benefit associated with dapagliflozin use outweighed the observed imbalance in specific malignancies or potential liver toxicity risks," they wrote.

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