Livalo, a New Statin, Gets FDA Nod

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FDA Approves New Cholesterol-Lowering Drug Livalo

By Daniel J. DeNoon
WebMD Health News

Reviewed By Brunilda Nazario, MD

Aug. 3, 2009 -- The FDA has approved a Livalo, a new cholesterol-lowering statin drug.

Known by the generic name of pitavastatin, Livalo has been used in Japan since 2003. It's also sold in Korea and Thailand.

Livalo is made by the multinational Japanese firm Kowa Company Ltd. Kowa now has facilities in the U.S.

Livalo will join the growing list of stains approved for U.S. sale:

• rosuvastatin (Crestor)
• fluvastatin (Lescol)
• atorvastatin (Lipitor)
• lovastatin (Mevacor)
• pravastatin (Pravachol)
• simvastatin (Zocor)

Statins are approved for patients unable to sufficiently lower their cholesterol levels by diet and exercise. All of the drugs work by inhibiting HMG Co-A reductase, a liver enzyme that makes cholesterol.

In a study presented at a recent scientific meeting, Danish researchers reported that a 4 milligram dose of Livalo was superior to a 40 milligram dose of Pravachol.

The FDA approval is based on five clinical studies showing that Livalo is as safe and as effective as three of the statins on the U.S. market.

SOURCES: News release, FDA. News release, Kowa Pharmaceuticals.

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