Livalo, New Cholesterol-Fighting Drug, Gets FDA Approval
If you are among the millions of Americans who need to reduce cholesterol to fight heart disease, stroke, and other serious conditions, you may soon have a new treatment option. Livalo, a statin drug used to lower cholesterol, has been approved by the U.S. Food and Drug Administration.
Livalo, known generically as pitavastatin, is made by Kowa Pharmaceuticals. It has been used for years in Japan, Korea, and Thailand, but only today earned approvals from U.S. drug-safety officials.
Livalo belongs to a class of cholesterol-lowering drugs called statins, a group that includes Crestor (rosuvastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Mevacor (lovastatin), Pravachol (pravastatin), and Zocor (simvastatin), the FDA said. Statins are among the most profitable drugs for pharmaceutical companies.
Statins may be prescribed to patients who cannot sufficiently lower their cholesterol levels by using exercise and diet. Livalo and other statins work by blocking a cholesterol-producing liver enzyme called HMG Co-A reductase.
Livalo can be used for the primary treatment of high cholesterol (also called hypercholesterolemia), combined dyslipidemia, or abnormal levels of fatty substances in the blood, the FDA said.
But statins are not without controversy. Recently released medical research concluded that statins may permanently damage muscle tissue for years after patients stop taking them. The class of drugs also has been associated with kidney damage and kidney failure.
Studies Support Approval, FDA Says
Danish researchers recently found that a four-milligram dose of Livalo outperformed a 40-milligram dose of Pravachol, a rival statin drug. In approving the drug for use in the U.S., the FDA also cited five clinical studies which found Livalo is just as safe and effective as other statins already on the market.
The studies found that Livalo reduced high levels of LDL cholesterol, the so-called “bad cholesterol” that is a leading contributor to medical problems such as cardiovascular disease. Livalo should be available in your local pharmacy in early 2010, Kowa officials said.
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