ARTICLE | Regulation

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What BMS, AstraZeneca must show FDA for dapagliflozin in diabetes

July 25, 2011 7:00 AM UTC

With an FDA panel wanting more data on diabetes candidate dapagliflozin from Bristol-Myers Squibb Co. and AstraZeneca plc, the pharmas' best bet is to convince the agency they can address safety concerns with further analyses of existing data and postmarketing studies.

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 last week against approving dapagliflozin. During the discussion, all the panelists agreed the sponsors need to show more safety and subpopulation data. They had mixed opinions on whether the data should be generated before or after approval, but that was not a question they were asked to vote on...