The U.S. Food and Drug Administration (FDA) today held an 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 United States) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease. In response to the Committee's majority recommendation to retain the Trilipix indication for co-administration with a statin and to obtain more clinical data to further support statin/fibrate combination use, Abbott (NYSE: ABT) issued the following statement:
"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, M.D, vice president, Global Pharmaceutical Clinical Development, Abbott. "We also appreciate the request for more clinical data and look forward to further discussions with the FDA."
The National Cholesterol Education Program (NCEP) treatment guidelines recommend consideration of the use of a fibrate with a statin in patients with triglycerides at or above 200 mg/dL who are at LDL cholesterol goal, but not at non-HDL cholesterol goal. Two thirds of patients in the ACCORD Lipid study would not qualify for treatment with fibrates under current guidelines. In this study, the median triglyceride level was 162 mg/dL.
The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA in its decision-making process on fenofibric acid.