Schering-Plough Corporation and Bayer HealthCare has announced that Zetia (ezetimibe), a novel cholesterol-lowering agent that inhibits the absorption of cholesterol in the intestine, is now available in Japan for use in patients with hypercholesterolemia, familial hypercholesterolemia or homozygous sitosterolemia.

Zetia is the first new cholesterol-lowering medication with a novel mechanism of action since statins were introduced 18 years ago in Japan. Zetia is marketed in Japan by Schering-Plough KK and Bayer Yakuhin Ltd., the country operations of Schering-Plough and Bayer HealthCare, respectively, in Japan.

Zetia can be used as a monotherapy and co-administered with a statin, for further reduction of low-density lipoproteins (LDL) or "bad" cholesterol.

Zetia received marketing approval in Japan from the Ministry of Health, Labour and Welfare (MHLW) on April 18, and will become available on June 11 following National Health Insurance Reimbursement price listing on June 8. The total number of patients in Japan with high cholesterol, including those undiagnosed, is estimated to be approximately 30 mn, which makes Japan the second leading country with patients with high cholesterol, following the US.

Schering-Plough, in collaboration with Merck, obtained FDA approval for Zetia in 2002, and the medication has been approved in 90 countries worldwide. The cholesterol-management market is one of the largest worldwide, with total global sales of $34 billion and sales in the United States of $22 billion in 2006.

Schering-Plough, in collaboration with Merck, has developed and commercialised Zetia for lipid management in the United States and the rest of the world (excluding Japan), where it is also marketed under the trade names Ezetrol and Zient.

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. Zetia, alone or in combination with statins, has been proven to significantly improve LDL cholesterol levels. Zetia, either alone or in addition to a statin, has not been shown to prevent heart disease or heart attacks.

Zetia is indicated, along with a healthy diet, for use either by itself or together with statins in patients with high cholesterol to reduce LDL cholesterol and total cholesterol when the response to diet has been inadequate.