The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved ZETIA® (ezetimibe), a novel cholesterol-lowering agent that inhibits the absorption of cholesterol in the intestines. ZETIA® will be co-marketed by Bayer Yakuhin Ltd. and Schering-Plough K.K. Japan. The drug is approved for use either as monotherapy or co-administered with a statin, for further reduction of LDL "bad" cholesterol.
ZETIA®, which works in the digestive tract to inhibit the absorption of cholesterol, is complementary to the class of cholesterol-lowering agents known as statins, which work in the liver to reduce the production of cholesterol. In a multi-center, randomized, double-blind, placebo-controlled 12-week clinical trial in 628 patients with high cholesterol, the co-administration of atorvastatin (10 mg, 20 mg, 40 mg, 80 mg) with ZETIA® 10mg lowered LDL "bad" cholesterol by an average of 53 to 61 percent from baseline across the dosing range compared to average LDL cholesterol reductions of 37 to 54 percent with atorvastatin alone.
The total number of hypercholesterolemia patients in Japan, including those undiagnosed, is estimated to be approximately 30 million. It is believed that, of these, about 80% are untreated.
The co-marketing agreement regarding ZETIA® is part of Bayer's strategic pharmaceuticals alliance with Schering-Plough, which was announced in 2004. Bayer's primary care pharmaceutical products, such as the antibiotics Avelox® and Cipro®, the cardiovascular product Adalat® and also Levitra® are today marketed and distributed by Schering-Plough in the United States and Puerto Rico.
Wed Apr 25, 2007 1:52 am