FDA's vote on Trilipix mixed, but unanimous that trial is needed

Members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met May 19 to determine the future of Abbott’s cholesterol drug fenofibrate (Trilipix), a drug indicated for co-administration with a statin. And while all 13 voting members voted unanimously in favor of Abbott conducting a clinical trial to gain more evidence, results were a mixed-bag as to whether the drug should allowed continued marketing, be pulled from the market or undergo a revision to its label.

The clinical trial will seek to assess whether or not add-on fenofibrate reduces the risk for major adverse cardiovascular events (MACE) in high-risk men and women with high triglycerides (TG) and low high-density lipoprotein cholesterol (HDL-C),who are at a low LDL-cholesterol on a statin.

In a statement, Abbott's Vice President of Global Pharmaceutical Clinical Development Eugene Sun, MD, said "Abbott appreciates the Committee's recognition that the totality of data, including ACCORD-Lipid, supports retaining the co-administration indication for Trilipix in appropriate patients."

Additionally, three of the voting members recommended allowing the continuation of marketing for the current fenofibrate indications for coadministration with a statin. While four members voted to withdrawal approval of the drug indication for co-administration with a statin, six members recommended allowing continued marketing of the drug but placing stricter labels on the drug to reflect the results of the ACCORD-Lipid trial.

Results of the ACCORD-Lipid trial found that administering fenofibrate with a statin did not significantly reduce MACE rates in diabetics.

The FDA will take into account recommendations from the voting members of the committee as it continues to determine the fate of fenofibrate, but is not required to followed its vote.