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FDA Approves TriLipix

[TriLipix is a follow-on to ABT’s TriCor, which is used as either a standlone cholesterol drug or in combination with a statin. Combination use is off-label for TriCor but it on-label for TriLipix. Moreover, ABT and AZN have joined forces on a TriLipix+Crestor combination pill, which has the potential to put the final nail in the Vytorin coffin. Until the combination pill is approved, ABT’s main goal will be to switch as many patients as possible from TriCor to TriLipix before the former goes generic in the US in 2011.]

http://finance.yahoo.com/news/Abbott-Receives-FDA-Approval-prnews-13836218.html

›Abbott Receives FDA Approval for TRILIPIX(TM) (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management

New Therapy in Combination with a Statin Helped Patients Improve HDL and LDL Cholesterol and Triglycerides in Clinical Studies

Monday December 15, 2008, 4:05 pm EST

ABBOTT PARK, Ill., Dec. 15 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIX™ (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 well as more aggressive management of HDL and triglycerides.

About the TRILIPIX Clinical Trial Program

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. Patients included in the studies had multiple lipid problems, with an LDL > 130 mg/dL, triglycerides > 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women. A total of 1,911 patients who completed one of the 12-week studies subsequently enrolled in a 52-week long-term, open-label extension study.

The Phase III combination studies all met their primary endpoints. Combination therapy significantly improved HDL and triglycerides compared to statin therapy alone, and significantly improved LDL compared to TRILIPIX alone. All of the combinations and the statins had clinically meaningful reductions in LDL.

"Physicians told us that they needed data supporting the use of a fibrate with statins to help them more aggressively manage their patients' lipid problems," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "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."

Abbott and AstraZeneca are working together to develop a fixed-dose combination of Abbott's TRILIPIX and AstraZeneca's CRESTOR® (rosuvastatin calcium) with plans to submit a new drug application to the FDA in 2009. The companies also recently announced an agreement under which Abbott's sales force will co-promote CRESTOR in the United States.

TRILIPIX Indications

TRILIPIX is a prescription medicine used along with diet in adults to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can be used alone or with another cholesterol-lowering medicine called a statin. TRILIPIX has not been shown to prevent heart disease or heart attack.

… About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.‹