FDA committee to vote on efficacy, safety of fenofibric acid
The FDA Endocrinologic and Metabolic Drugs Advisory Committee will today discuss the future of fenofibric acid.
The panel is expected to vote whether the FDA should require a clinical trial to test whether fenofibric acid vs. placebo significantly lowers the risk for major adverse cardiac events in high-risk men and women with high triglycerides and low HDL. The committee will also vote whether the FDA should allow continued marketing of the current indication of coadministration with a statin; revise labeling to incorporate new data; or revoke approval.
Results of the Action to Control Cardiovascular Risk Diabetes (ACCORD) Lipid trial will be at the center of the discussion. The randomized, double blind, placebo-controlled, add-on trial evaluated the efficacy and safety of adding fenofibric acid (Trilipix, Abbott) to simvastatin (Zocor, Merck) therapy in more than 5,500 patients with type 2 diabetes. During an average 5 years, researchers found no significant difference in the proportion of patients treated with simvastatin plus placebo (11.3%) vs. simvastatin plus fenofibric acid (10.5%) who experienced a major adverse cardiac event (HR=0.92; 95% CI, 0.79-1.08). However, results of a prespecified subgroup analysis showed an increase in the proportion of women treated with simvastatin plus fenofibric acid (9.1%) vs. simvastatin plus placebo (6.6%) who experienced a major adverse cardiac event. An additional safety concern associated with the use of fenofibric acid plus simvastatin, or any other statin, is muscle toxicity. The ACCORD-Lipid trial data were presented in March 2010 at the American College of Cardiology 59th Annual Scientific Sessions. Shortly after the results were released, the FDA announced its plans to review the ACCORD-Lipid trial data.
Fenofibric acid is the active ingredient of fenofibrate. Fenofibrate is a peroxisome proliferator-activated receptor-alpha agonist (PPAR-alpha) that was approved for the treatment of hypertriglyceridemia in 1993. In 2009, the FDA approved the new drug application for fenofibric acid in combination with a statin.
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