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Abbott Receives FDA Approval for TRILIPIX(TM) (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management
Date:12/15/2008

ABBOTT PARK, Ill., Dec. 15 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIX(TM) (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX 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.

"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."

TRILIPIX was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids affecting millions of American adults. In the TRILIPIX studies, mixed dyslipidemia was characterized by elevated LDL (bad cholesterol) and triglycerides (a type of fat found in the blood) and low HDL (good cholesterol). These studies demonstrated that TRILIPIX used in combination with the most commonly prescribed statins helped patients manage all three key lipids better than the corresponding therapies alone.

Treatment guidelines endorsed by the National Cholesterol Education Program (NCEP), the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as w
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