Avandia Review Endorsement Aided By Good Data, Cultural Shift On Safety
Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.
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As The Medicines Co.’s anticlotting drug heads to the Cardiovascular and Renal Drugs Advisory Committee, questions about comparator dosing and timing and the severity of bleeding events will be on the agenda.
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.