FDA advisory panel backs continued use of Abbott's Trilipix with statins

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee to review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix in the USA by health care major Abbott Laboratories [NYSE: ABT]) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease.

The Committee voted by a majority - nine out of 13 - to recommend retention of  the Trilipix indication for co-administration with a statin but to obtain more clinical data to further support statin/fibrate combination use. Six panelists voted that the label should be updated with results from the government study. Three said the labeling does not need to be changed.

"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," said Eugene Sun, vice president, global pharmaceutical clinical development, at Abbott, adding: "We also appreciate the request for more clinical data and look forward to further discussions with the FDA."