FDA Approves LIVALO Statin for Primary Hypercholesterolemia, Combined Dyslipidemia

 

August 4, 2009

August 3, 2009 – Kowa Research Institute (KRI) and Kowa Pharmaceuticals America Inc. (KPA) said today the FDA has cleared LIVALO (pitavastatin), a potent HMG-CoA reductase inhibitor (statin) for the primary treatment of hypercholesterolemia and combined dyslipidemia.

The company said the drug offers a new therapeutic option to a large, competitive market for cardiometabolic disorders.

"LIVALO has a robust safety, efficacy and tolerability profile and offers an attractive alternative for patients with primary hypercholesterolemia or combined dyslipidemia," said Antonio M. Gotto Jr., M.D., D.Phil, the Stephen and Suzanne Weiss Dean of Weill Medical College of Cornell University, New York. "LIVALO has very positive attributes that will help continue to fill current unmet needs in the statin market for clinically complex patient populations, such as the elderly, patients with diabetes or patients who take multiple medications for co-morbid conditions."

LIVALO is a fully synthetic and highly potent statin engineered in Japan. LIVALO differs from other, currently available statins in the U.S. in that it has a unique cyclopropyl group on the base structure, the company said. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol. 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 company said. The overall safety and tolerability of LIVALO are consistent with other commonly prescribed statins.
LIVALO is expected to launch in the U.S. during the first quarter of 2010 and will be available in three 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.

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 elevated level of cholesterol in the blood is called hypercholesterolemia, commonly referred to as high cholesterol. Dyslipidemia is well established as one of the strongest independent predictors of cardiovascular morbidity and mortality.

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