Avandia Committee Gives Split Vote To Drug, But FDA Clear Winner
A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.
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Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.
Large outcomes studies showed neither cardiovascular harm nor benefit with BMS/AstraZeneca’s saxagliptin or Takeda’s alogliptin, prompting some commenters to question whether FDA’s blanket approach to CV safety for all antidiabetic agents needs adjustment.