Lilly and Kowa's Livalo meets primary endpoint of LDL-C reduction

Presenting at the National Lipid Association's (NLA) Scientific Sessions in Scottsdale, Arizona, USA, Kowa Pharmaceuticals America, a subsidiary of privately owned Japanese firm Kowa, and US drug major Eli Lilly (NYSE: LLY) announced positive results of the PREVAIL US study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the USA) which evaluated the efficacy of Livalo (pitavastatin) 4mg compared with pravastatin 40mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Livalo was launched in the USA by Lilly and Kowa two years ago, following Food and Drug Administration approval (The Pharma Letter June 23, 2010).Under an accord signed in 2009, Lilly and Kowa Pharmaceuticals America co-promote Livalo in the US market, with both companies providing sales force resources and sharing development and marketing costs.

PREVAIL US was designed as a superiority trial for the primary endpoint, LDL-C reduction, and evaluated the adult population aged 18-80 with primary hyperlipidemia or mixed dyslipidemia. Livalo 4mg showed superior LDL-C reduction compared with pravastatin 40mg after 12 weeks of therapy. The study did not compare Livalo 4mg with pravastatin 80mg.