May 19th, 2011
FDA Panel Delivers Mixed Verdict on Trilipix (Fenofibrate)
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee delivered a mixed verdict on fenofibrate (Trilipix, Abbott). On the one hand, the panel agreed unanimously that the FDA should require Abbott to perform a large clinical trial in high-risk patients with elevated triglyceride levels and low HDL levels who nevertheless have achieved target LDL cholesterol levels on statin therapy.
On the other hand, 9 panelists voted to keep (3 votes) or incorporate the findings from ACCORD (6 votes) in the current label. Four panelists voted to withdraw the indication.