Eli Lilly and Kowa Pharma debut new statin Livalo in USA

US drug major Eli Lilly and partner Kowa Pharmaceuticals America (a subsidiary of Japan's Kowa) have this week launched their new cholesterol lowerer Livalo (pitavastatin) through retail pharmacists in the USA.

Livalo was approved by the US Food and Drug Administration in August 2009 for the treatment of adults as an adjunctive therapy to diet for primary hyperlipidemia or mixed dyslipidemia. It is the subject of a co-promotion accord - which includes Latin America 'signed by the two companies last year, financial terms of which were not disclosed. The drug is available in doses of 1mg, 2mg and 4mg.

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 low-density lipoprotein cholesterol (LDL-C) lowering of up to 39% at a 2mg dose and up to 45% at a 4mg dose.