FDA Approves Trilipix
Abbott Receives FDA Approval for Trilipix (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
ABBOTT PARK, Ill., December 15, 2008 /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, 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(R) (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 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.
Important Safety Information About Trilipix
Trilipix should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient. Unexplained muscle pain, tenderness, or weakness may be a sign of a serious side effect and should be reported to a healthcare provider right away. Rarely, muscle-related problems can cause kidney damage. These side effects may be increased when Trilipix is used with a statin. Patients should tell their healthcare provider about all the medicines they take to help avoid serious side effects. Blood tests may be performed before and during treatment with Trilipix. Patients should contact their healthcare provider if they experience abdominal pain, nausea or vomiting while taking Trilipix. These may be signs of inflammation of the gallbladder or pancreas. Women who are pregnant should not take statins and should talk with their healthcare provider about Trilipix if they are pregnant or may become pregnant. The most common side effects with Trilipix include headache, heartburn, nausea, muscle aches and increases in muscle or liver enzymes that are measured by blood tests. Full Prescribing Information is available at http://www.rxabbott.com/pdf/Trilipix_pi.pdf. Visit http://www.trilipix.com or call Abbott Medical Information at 1-800-633-9110 for more information about Trilipix.
Abbott 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.
CONTACT: Media, Elizabeth Hoff, +1-847-935-4236, or Financial, LawrencePeepo, +1-847-935-6722, both of Abbott
Web site: http://www.abbott.com/
Ticker Symbol: (NYSE:ABT)
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Posted: December 2008
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