Bayer/S-P's Zetia approved in Japan

The Japanese Ministry of Health, Labor and Welfare has approved German drug major Bayer's Zetia (ezetimibe). The novel cholesterol-lowering agent that inhibits the absorption of cholesterol in the intestines will be co-marketed by Bayer's local unit and Schering-Plough KK Japan. The drug is approved for use either as monotherapy or co-administered with a statin, for further reduction of low-density lipoprotein. In a multicenter, randomized, double-blind, placebo-controlled 12-week trial in 628 patients with high cholesterol, the co-administration of atorvastatin plus Zetia lowered LDL an average of 53% to 61% from baseline versus LDL reductions of 37% to 54% with atorvastatin alone.