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news.Abbott Laboratories has announced that the FDA has approved its Trilipix delayed-release capsules for use along with diet to help lower triglycerides and low-density lipoprotein cholesterol, and to raise high-density lipoprotein cholesterol in patients with lipid problems.
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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. The Phase III combination studies all met their primary endpoints.
Trilipix is said to be 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.
Abbott and AstraZeneca are working together to develop a fixed-dose combination of Abbott’s Trilipix and AstraZeneca’s Crestor with plans to submit a new drug application to the FDA in 2009.
Eugene Sun, vice president of global pharmaceutical clinical development at Abbott, said: Abbott built a robust clinical program to support the use of Trilipix, and its approval adds a new option to Abbott’s growing dyslipidemia portfolio which provides treatments to comprehensively help address all three key lipids.