FDA Panel Recommends Further Study, But Continued Use, of Trilipix With Statin

The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee May 19 unanimously called for a further clinical trial of Trilipix (fenofibric acid) to evaluate whether adding the drug to statin treatment “significantly lowers the risk for major adverse cardiac events,” an FDA spokeswoman told BNA via e-mail.

The panel was examining Abbott Laboratories’ Trilipix, which FDA approved in late 2008 (6 PLIR 1413, 12/19/08). In a vote with three options on continued marketing of the drug, the most popular option was allowing continued marketing of Trilipix with a statin but with revised labeling to incorporate findings ...