Avandia RECORD Study Re-Analysis To Get FDA Committee Scrutiny
This article was originally published in The Pink Sheet Daily
Two FDA panels will jointly review an independent “re-adjudication” of GlaxoSmithKline’s RECORD study of Avandia’s cardiovascular risk; 12 of 33 panel members voted to withdraw the drug when they considered the RECORD data in 2010.
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More than half of a 26-member advisory committee supports eliminating or easing the REMS for GSK’s diabetes drug, but the spilt vote and high-profile of the product’s safety issues suggest that FDA is unlikely to modify Avandia’s risk management.
Two advisory panels will revisit the question of whether FDA should withdraw GlaxoSmithKline’s Avandia from the market as a reevaluation of the cardiovascular trial produces results similar to the original findings; the data does not seem to offer much more clarity, but does give the agency a chance to argue it handled previous controversies well.
Currently the head of the Division of Metabolic and Endocrinology Products, Parks has handled drug safety controversies in diabetes and obesity products.