LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Jun 21 2010

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States.  LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia.  LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

LIVALO, approved on the basis of 10 clinical trials, including five 12-week clinical trials comparing efficacy and safety to three currently FDA-approved statins (atorvastatin, simvastatin, and pravastatin), offered LDL cholesterol (LDL-C) lowering of up to 39 percent at a 2 mg dose and up to 45 percent at a 4 mg dose.

While few drugs, including LIVALO, are free from drug-drug interactions, LIVALO may be an attractive option for physicians treating patients taking multiple medications because its potential for cytochrome P450-mediated drug-drug interactions is low.  LIVALO is only minimally metabolized by the cytochrome P450 system in the liver, which is important because this system is involved in approximately 75 percent of all drug metabolism.

"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," said Michael Davidson, M.D. Director of Preventive Cardiology, University of Chicago Pritzker School of Medicine.

"LIVALO has been the leading product in our cardiovascular portfolio in Asia since 2003," said Ben Stakely, president and CEO of Kowa Pharmaceuticals. "We are excited to bring our flagship product to the U.S. to help patients reach their LDL-C 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," said Javan Collins, vice president of Cardiovascular Business Unit, Lilly.  "LIVALO offers physicians another option for patients trying to lower their LDL-C."

Kowa Pharmaceuticals and Lilly last year announced a co-promotion agreement to commercialize LIVALO in the U.S. in which both companies will provide sales force resources and share development and commercialization costs.