Trilipix fenofibric acid regulatory update

FDA is requiring Abbott to conduct a new clinical trial to evaluate the cardiovascular effects of Trilipix fenofibric acid after completing a review of the ACCORD Lipid trial. The trial 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 events. The agency also updated the label for the next-generation version of fenofibrate to state that the cholesterol drug may not lower a patient's risk of heart attack or stroke. In May, an FDA advisory committee voted 13-0 in favor of an additional study (see BioCentury, May 23).

Trilipix is indicated in combination with a statin in high-risk patients with mixed dyslipidemia, and as monotherapy in patients with severe hypertriglyceridemia, primary hyperlipidemia or mixed dyslipidemia. ...