S-P/Bayer's Zetia launched in Japan

US drug major Schering-Plough and Germany-based Bayer HealthCare say 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.

The agent is the first new cholesterol-lowering medication with a novel mechanism of action since statins were introduced 18 years ago in Japan. The drug will be marketed by Schering-Plough KK and Bayer Yakuhin, the local units of the two drugmakers.

Zetia can be used as a monotherapy and co-administered with a statin, for further reduction of low-density lipoproteins or bad cholesterol. The agent received marketing approval in Japan from the Ministry of Health, Labor and Welfare on April 18, and became available on June 11 following National Health Insurance Reimbursement price listing (Marketletter June 11). The total number of patients in Japan with high cholesterol, including those undiagnosed, is estimated to be approximately 30 million, which makes Japan the second leading country with patients with high cholesterol, after the USA.