FDA OKs Abbott’s New Cholesterol Drug Trilipix

The Food and Drug Administration (FDA) has approved the new drug Trilipix, for use along with diet to lower bad cholesterol (LDL) and triglycerides and raise the good cholesterol or (HDL) in patients with lipid problems.

Abbott Laboratories (ABT) delayed-release capsules of Trilipix belong to a class of drugs called fibrates that includes other drugs such as gemfibrozil (sold generically and under the brand name Lopid), fenofibrate (sold under the brand names Antara, Lofibra, Tricor, and Triglide), and clofibrate (sold under the brand name Atromid-S).

The company calls Trilipix "the first and only fibrate indicated for use in combination with a statin for cholesterol management" but notes that "Trilipix has not been shown to prevent heart disease or heart attack."

Michael Davidson, a clinical professor at the University of Chicago's Pritzker School of Medicine said, "Only 35% of patients with lipid problems are currently being treated with lipid therapies, and many are not reaching treatment targets for all three key lipids. 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 FDA approval for Trilipix Abbott states is based on clinical trials that included nearly 2,700 patients with high levels of LDL cholesterol and triglycerides and low HDL levels. Some of the patients took cholesterol-lowering drugs called statins; others took statins and Trilipix. LDL levels dropped for all patients, but in patients taking statins and Trilipix the improvement in HDL and triglyceride levels was greater.

Abbott is working with AstraZeneca, on making a combination pill that combines Trilipix and Crestor, a statin made by AstraZeneca and the companies plan to submit that drug application to the FDA in 2009, according to Abbott.

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