December 15, 2008 - The FDA has approved Abbott's TRILIPIX (fenofibric acid) delayed-release capsules, the first and only fibrate indicated for use in combination with a statin for cholesterol management.
The drug is indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. 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, University of Chicago 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."
The TRILIPIX clinical trial program was 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.
For more information: www.trilipix.com