ALERT: New Statin Drug, Livalo Receives FDA Nod
August 19, 2009
Livalo® (pitavastatin | Kowa Pharmaceuticals America, Inc.), a potent statin, has gained the U.S. Food and Drug Administration (FDA) approval for the primary treatment of hypercholesterolemia and combined dyslipidemia. Livalo was discovered by a Japanese company Nissan Chemical Industries, Ltd. and developed further by Kowa Pharmaceuticals, Tokyo. It has been marketed in Japan since 2003 under the same brand name.
FDA has given the marketing authorization based on positive results obtained in five trials comparing its efficacy and safety with other statins. Pivotal phase III trials demonstrated the ability of Livalo in effectively reducing low density lipoprotein-C (LDL-C) and positively affecting other parameters of lipid metabolism. The safety profile was found to be similar to other statins, and the most commonly reported side effects were muscle, back and joint pain, and constipation.
The drug acts by inhibiting the enzyme HMG-CoA reductase, the rate-limiting enzyme in the cholesterol synthesis pathway. Other drugs belonging to this group include atorvastatin, simvastatin, lovastatin and fluvastatin. Livalo possesses a unique cyclopropyl group in its base structure, which makes the drug a more effective inhibitor of HMG-CoA reductase than the other statins. Moreover, the drug is converted to the inactive lactone form after glucuronidation and is only minimally metabolized by the cytochrome P450 pathway, lowering the risk of drug interactions. The drug can be prescribed in clinically complex patient populations such as the elderly, diabetics, and those with other co-morbid conditions.
According to the Centers for Disease Control and Prevention (CDC), hypercholesterolemia (≥240 mg/dL) affects 17% of adult Americans and is a major risk factor for cardiovascular disease. Fat-rich diet, overweight, physical inactivity, heredity, and advancing age are some of the contributing factors to increased cholesterol levels. The high density lipoprotein (HDL) levels tend to be lower in men than in women. Also, the low density lipoprotein (LDL) levels are lower in younger women than men, but higher after the age of 55 years. Apart from recommendations on diet and exercise, a suitable statin is generally prescribed in persons with hypercholesterolemia to lower blood cholesterol and maintain it in the target range.
About Kowa Pharmaceuticals America, Inc.: Headquartered in Montgomery, Alabama, the pharmaceutical company mainly focuses on developing products for cardiology, pain and migraine. The company was originally formed in 2008, through the acquisition of ProEthic Pharmaceuticals, Inc. in 2001 by the Japanese Kowa Company, Ltd. Livalo (pitavastatin) is the first drug to be launched by the new company.
References
1. FDA Approves New Cholesterol-Lowering Drug. Press release. FDA. Last accessed August 10, 2009.
2. Hayashi T, Yokote K, Saito Y, Iguchi A. Pitavastatin: efficacy and safety in intensive lipid lowering. Expert Opin Pharmacother. 2007 Oct;8(14):2315-27.
3. Cholesterol. CDC. Last accessed August 10, 2009.
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