Panel splits on future of Trilipix

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-0 late Thursday in favor of requiring an additional study to evaluate whether Trilipix fenofibric acid plus a statin significantly lowers the risk of cardiovascular events in high-risk patients with mixed dyslipidemia. However, the panel was split on the topic of what regulatory action to take for the indication while the additional trial is conducted. Three members voted to allow continued marketing of the indication without a label revision; four voted to withdraw approval; and six voted to allow continued marketing with a label revision to include results from the ACCORD Lipid trial.

The committee considered results of ACCORD Lipid, which showed that fenofibrate plus simvastatin did not significantly reduce the rate of cardiovascular events vs. simvastatin alone in Type II diabetics who were at high risk for cardiovascular disease events (see BioCentury Extra, March 15, 2010). ...