Rockville, MD - The US Food and Drug Administration has approved pitavastatin (Livalo, Kowa Pharmaceuticals America Inc), a new cholesterol-lowering drug for the primary treatment of hypercholesterolemia and combined dyslipidemia.
Pitavastatin is the newest addition to the drug class, joining atorvastatin, rosuvastatin, simvastatin, pravastatin, lovastatin, and fluvastatin on the crowded statin market. The drug is expected to launch in the US in early 2010 and will be available in three low dosages: 1 mg, 2 mg, and 4 mg. It is has been available in Japan since 2003, and is also available in South Korea, Thailand, and China.
According to the FDA, the drug was approved on the basis of results from five clinical trials showing that pitavastatin was as safe and effective as other statins on the market [1]. A press release issued by the company notes that the studies showed the drug to be particularly effective in special populations, including the elderly, patients with diabetes, and those at higher cardiovascular risk [2].
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