FDA Approves Kowa's Livalo

Livalo (pitavastatin) belongs to a group of medicines called HMG CoA reductase inhibitors, or "statins." Livalo reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Livalo is used to treat high cholesterol in adults. Lowering your cholesterol may help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

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. 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. 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.

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

Primary Hyperlipidemia and Mixed Dyslipidemia

LIVALO is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use

Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of LIVALO.

The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.

General Information About Livalo:

Pitavastatin (brand name: Livalo) is a cholesterol-lowering medication that belongs to the statin class of drugs. It is one of the more potent statins on the market. According to studies conducted by Kowa Pharmaceuticals, the manufacturers of Livalo, 2 mg of Livalo is as efficient at lowering lipids as 10 mg of Lipitor (atorvastatin). Additionally, 2 mg of Livalo lowers cholesterol to an extent similar to 20 mg of Zocor (simvastatin).

Like other statins, Livalo affects all aspects of your cholesterol profile: It lowers LDL and triglycerides, and raises HDL.

Livalo is not currently available in generic form.

How Livalo Works:

Livalo blocks an enzyme called 3-hydroxy-3methylglutaryl coenzyme A (HMG CoA) reductase, which is an important protein needed in the production of cholesterol.