FDA approves Abbott’s Trilipix for lowering cholesterol

12/16/2008

ABBOTT PARK, Ill. The Food and Drug Administration has approved a new cholesterol-lowering drug by Abbott, the drug maker announced Monday.

Abbott announced that it had received approval for the drug Trilipix (fenofibric acid), a drug for use along with changes in diet to help lower triglycerides and LDL cholesterol and raise HDL cholesterol. The company said it is the only fibrate to be approved for use in combination with a statin, though Trilipix has not been shown to prevent heart disease or heart attack.

“Only 35 percent of patients with lipid problems are currently being trated with lipid therapies, and many are not reaching treatment targets for all three key lipids,” said Michael Davidson, clinical professor and director of preventive cardiology at the University of Chicago Pritzker School of Medicine, in a statement by Abbott. “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 drug was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids that affects millions of American adults, characterized by elevated LDL cholesterol and triglycerides and lower HDL cholesterol.

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