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Kowa Pharmaceuticals, Lilly launch Livalo

Kowa Pharmaceuticals America Inc. and Eli Lilly and Co. have rolled out cholesterol-lowering drug Livalo to retail pharmacies in the United States. The drug makers said Monday that Livalo (pitavastatin) is available in 1 mg, 2 mg and 4 mg tablets.

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MONTGOMERY, Ala. and INDIANAPOLIS — Kowa Pharmaceuticals America Inc. and Eli Lilly and Co. have rolled out cholesterol-lowering drug Livalo to retail pharmacies in the United States.

The drug makers said Monday that Livalo (pitavastatin) is available in 1 mg, 2 mg and 4 mg tablets.

Livalo is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia, according to Kowa and Lilly.

Hyperlipidemia is a condition of high levels of fatty substances in the blood, including elevated cholesterol and a high level of triglycerides. Mixed dyslipidemia is usually marked by an elevation of total cholesterol, low-density lipoprotein (LDL, or "bad cholesterol") and triglyceride levels and a decrease in high-density lipoproteins (HDL, or "good cholesterol") in the blood.

Kowa and Lilly said clinical trials have shown Livalo to lower LDL cholesterol up to 39% at a 2 mg dose and up to 45% at a 4 mg dose. The companies added that Livalo also may be an attractive option for doctors treating patients taking multiple medications.

"Since many patients treated for elevated cholesterol may be on multiple medications, it is important that physicians and pharmacists caring for these patients understand how treatment with a cholesterol medication, such as a statin, may potentially interact with the other drugs the patient may be taking," Michael Davidson, M.D., director of preventive cardiology at the University of Chicago Pritzker School of Medicine, said in a statement.

The Food and Drug Administration approved Livalo in August 2009. Kowa and Lilly last year announced a co-promotion agreement to commercialize the statin medication in the United States.

"Livalo has been the leading product in our cardiovascular portfolio in Asia since 2003," commented Ben Stakely, president and chief executive officer of Kowa Pharmaceuticals. "We are excited to bring our flagship product to the U.S. to help patients reach their LDL cholesterol goals."

"Lilly is committed to providing innovative solutions to patients in need and is excited to collaborate with Kowa Pharmaceuticals America Inc. to bring this new statin to the market," stated Javan Collins, vice president of Lilly’s cardiovascular business unit. "Livalo offers physicians another option for patients trying to lower their LDL cholesterol."

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