FDA committee doesn't recommend regulatory approval for dapagliflozin

WILMINGTON, Del. — A Food and Drug Administration committee of experts has advised against approving a drug for Type 2 diabetes made by AstraZeneca and Bristol-Myers Squibb, the companies said Tuesday.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 against recommending approval for dapagliflozin, saying that data from a two-year clinical trial program that included about 6,000 people did not support the drug’s approval for use in patients along with changes to diet and exercise.

The FDA is not required to follow advisory committee votes but usually does. Shares of AstraZeneca were down about 0.6%, while Bristol’s shares were up about 0.17% Wednesday morning.

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