Avandia Should Stay On Market, Committee Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Joint advisory committee concludes, however, that the thiazolidinedione raises cardiovascular risk.
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Unpersuaded by a recommendation from FDA's Office of Surveillance and Epidemiology to withdraw GlaxoSmithKline's Avandia from the market due to cardiovascular risks, a joint panel of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees determined that the diabetes medication's risk-benefit profile supports its continued marketing July 30. Despite concluding that available data suggest that Avandia (rosiglitazone) increases cardiac ischemic risk in type 2 diabetes patients, the committee voted 22 to one that the weakness of the safety data coupled with medical need for the drug outweighed the safety concerns. The lopsided vote may prove to be a turning point in an internal debate within the Center for Drug Evaluation and Research about the appropriate regulatory steps to take following the emergence of a cardiac safety signal (1 (Also see "Avandia Safety Under The Microscope" - Pink Sheet, 21 May, 2007.)). "There is a fundamental disagreement within CDER on the scientific conclusions that should be drawn from the information available," Office of Drug Evaluation II Director Robert Meyer noted. The committee criticized the recommendation of OSE Director Gerald Dal Pan and OSE Associate Director for Science and Medicine David Graham to pull the drug based in part on a preliminary comparison of Avandia to the other marketed thiazolidinedione, Lilly/Takeda's Actos (pioglitazone). "You compared rosiglitazone to pioglitazone and ... I think the evidence for that comparison is pretty minimal," Nancy Geller, National Heart, Lung and Blood Institute said. FDA requested a meta-analysis of Actos data, similar to the one submitted by GSK, but a full analysis was not complete in time for the meeting. -Brian Marson ([email protected]) |