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Bristol-Myers, AstraZeneca Diabetes Drug Turned Down by FDA Panel
By Market News Video Staff, Wednesday, July 20, 10:06 AM ET
An advisory committee of the U.S. Food and Drug Administration late yesterday voted against a recommendation to approve a diabetes drug jointly developed by Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN).
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 6 yes, 9 no in regards to whether the efficacy and safety data provide substantial evidence to support approval of the new drug application for dapagliflozin in treating type 2 diabetes.
The FDA typically takes the recommendation of its advisory committees, although it is not required to do so.
The companies said they will continue to work closely with the FDA to support its review of the drug.
Bristol-Myers shares are trading flat Wednesday while AstraZeneca shares trade down 0.5%.
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