FDA Approves New Cholesterol Medication – Trilipix

Trilipix (fenofibric acid) is the first and only fibrate indicated for use in combination with a statin for controlling cholesterol. ilipix In combination with a statin, HDL, LDL and Triglycerides all improved in study.

Last week,  the U.S. Food and Drug Administration (FDA) approved Abbott’s TRILIPIX(TM) (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TRILIPIX has not been shown to prevent heart disease or heart attack.

“Only 35 percent of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all three key lipids,” said Michael Davidson, M.D., clinical professor and director of Preventive Cardiology, Pritzker School of Medicine. “The approval of TRILIPIX is good news for patients because now there is a new treatment option that can be used alone or in combination with a statin to help address lipid problems.”

TRILIPIX was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids affecting millions of American adults.

The FDA’s approval of TRILIPIX was based on the largest clinical trial program to date designed to evaluate the efficacy and safety of a fibrate in combination with various statins. The efficacy and safety of TRILIPIX in combination with the three most commonly prescribed statins — rosuvastatin, atorvastatin and simvastatin — was evaluated in three randomized, multicenter, double-blind, controlled, 12-week Phase III studies, totaling 2,698 patients with mixed dyslipidemia. Patients included in the studies had multiple lipid problems, with an LDL > 130 mg/dL, triglycerides > 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women. A total of 1,911 patients who completed one of the 12-week studies subsequently enrolled in a 52-week long-term, open-label extension study.

The Phase III combination studies all met their primary endpoints. Combination therapy significantly improved HDL and triglycerides compared to statin therapy alone, and significantly improved LDL compared to TRILIPIX alone. All of the combinations and the statins had clinically meaningful reductions in LDL.

Abbott and AstraZeneca are working together to develop a fixed-dose combination of Abbott’s TRILIPIX and AstraZeneca’s CRESTOR(R) (rosuvastatin calcium) with plans to submit a new drug application to the FDA in 2009. The companies also recently announced an agreement under which Abbott’s sales force will co-promote CRESTOR in the United States.

TRILIPIX is a prescription medicine used along with diet in adults to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can be used alone or with another cholesterol-lowering medicine called a statin. TRILIPIX has not been shown to prevent heart disease or heart attack.

Full Prescribing Information is available at https://www.rxabbott.com/pdf/trilipix_pi.pdf. Visit https://www.trilipix.com or call Abbott Medical Information at 1-800-633-9110 for more information about TRILIPIX.