FDA clears Abbott cholesterol drug Trilipix

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The FDA has approved Abbott Laboratories’ Trilipix delayed-release capsules along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems.  

The Abbott Park, Ill.-based company said that Trilipix (fenofibric acid) 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, the company said.

Trilipix was studied in 2,698 patients with mixed dyslipidemia, characterized by elevated LDL and triglycerides and low HDL. The company said that the studies demonstrated that Trilipix used in combination with the most commonly prescribed statins helped patients manage three key lipids better than the corresponding therapies alone.