All Trilipix Options Available To Advisory Committee
This article was originally published in The Pink Sheet Daily
ACCORD-Lipid trial results could lead members to recommend conducting another trial, revising the label, withdrawing the indication or take no action for Trilipix coadministration with a statin.
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The agency's Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 19 to consider how cardiovascular outcomes data on fenofibrate use in combination with simvastatin relate to the efficacy and safety of Trilipix, Abbott's second-generation fenofibrate product.
NDA for the TriLipix/Crestor combination drug is the subject of an FDA "complete response" letter.
Report from ACC: Experts advise reading the fine print of the study - which failed to show an overall outcome benefit - as sub-group analysis shows highest-risk patients might benefit.