Bristol-Myers Squibb, AstraZeneca diabetes drug hits speed bump at FDA

Agency issues complete response letter for dapagliflozin

PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

AstraZeneca and Bristol announced that they had received a complete response letter from the FDA for dapagliflozin. The agency said it would need more data to better weigh the drug's benefits against its risks. The FDA issues a complete response letter when it has finished reviewing a regulatory approval application, but questions remain that preclude approval of the application in its present form.

The companies said they would work closely with the agency to determine the next steps and were also communicating with health authorities in other countries.

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