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FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia
Date:8/3/2009

ly affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol. Importantly, pitavastatin is only minimally metabolized by the liver through the cytochrome P450 pathway, through which many other medications are metabolized.

In pivotal Phase III trials, LIVALO effectively reduced LDL-C and improved other parameters of lipid metabolism in special patient populations, including the elderly, patients with diabetes and patients at higher cardiovascular risk. The overall safety and tolerability of LIVALO are consistent with other commonly prescribed statins.

LIVALO is expected to launch in the U.S. during Q1 of 2010 and will be available in 3 low dosages (1 mg, 2 mg and 4 mg). After a thorough review of the statin market, KPA is also seeking a co-promotion partner in order to broaden the reach of KPA's rapidly growing internal sales force. Partnering with another organization to expand the sales efforts for this product is aligned with KPA's long-term vision to become a leader in the cardiometabolic therapeutic arena.

Since its launch in Japan, South Korea, Thailand and China, LIVALO has been successfully used in these countries to treat primary hypercholesterolemia and combined dyslipidemia, and has accumulated millions of patient-years of exposure. It is frequently prescribed in these countries as first-line therapy for a broad range of patients including the elderly, patients with diabetes and those whose treatment is complicated by concurrent disease and concomitant medications.

About Dyslipidemia and Hypercholesterolemia

Dyslipidemia refers to abnormal levels of fatty substances in the blood, or a disorder of the production or breakdown process of lipoprotein. Dyslipidemia may be marked by an elevation of total cholesterol, LDL-C, and triglyceride (TG) concentrations and a decrease in HDL-C in the blood. An elev
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SOURCE Kowa Pharmaceuticals America, Inc.
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