Abbott statement on the FDA Advisory Committee recommendations on fenofibric acid

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 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.

Trilipix Uses

Trilipix (fenofibric acid) delayed-release capsules is a prescription medicine that can be used along with diet to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. Trilipix can also be used along with diet to lower triglycerides and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol. Trilipix has not been shown to prevent heart attacks or stroke more than a statin alone.

Important Safety Information

• Trilipix should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient.
• Unexplained muscle pain, tenderness, or weakness, particularly when occurring with tiredness and fever, may be a sign of a serious side effect and should be reported to your healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and can be fatal. The risk of these side effects may be increased when Trilipix is used with a statin.
• Patients should tell their healthcare provider about all the medicines they take.
• Blood tests should be performed before and during treatment with Trilipix to check for liver and kidney problems.
• Patients should contact their healthcare provider if they experience abdominal pain, nausea or vomiting while taking Trilipix. These may be signs of inflammation of the gallbladder or pancreas.
• Women who are pregnant should not take statins and should talk with their healthcare provider about Trilipix if they are pregnant or may become pregnant.
• The most common side effects with Trilipix include headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that are measured by blood tests.

For more information, patients should talk with their health care provider. Full prescribing information for Trilipix (fenofibric acid) is available at http://www.rxabbott.com/pdf/trilipix_pi.pdf.