FDA advisory committee to discuss safety, efficacy of Trilipix

SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee will discuss results of the “ACCORD Lipid” study, which examined Abbott’s drug Trilipix (fenofibric acid) delayed-release capsules, which belongs to the drug class known as fibrates, in combination with the drug simvastatin in patients with Type 2 diabetes.

According to the announcement, the trial found no significant difference between patients treated with Trilipix and simvastatin vs. placebo and simvastatin in terms of the proportion that experienced heart attacks. In addition, an analysis of female patients found that those who took Trilipix and simvastatin experienced more heart attacks than those in the placebo group, but the announcement stated that the clinical significance of the finding was unclear.

The committee will vote on whether to maintain the drug’s approval for use with a statin, change the labeling to include information from the study or withdraw the approval. FDA advisory committee rulings are not considered binding, but the FDA takes them into consideration and usually follows them.

“We believe that the body of evidence clearly supports the use of fibrate treatment in appropriate patients … and that the data from 'ACCORD Lipid' is supportive of the indication for co-administration with a statin,” Abbott spokeswoman Elizabeth Hoff told Drug Store News.

Trilipix also is approved for use as a stand-alone therapy.