Schering-Plough’s cholesterol drug approved in Japan

Zetia is the first new cholesterol-lowering medication with a novel mechanism of action since statins were introduced 18 years ago in Japan, according to the companies. The drug is marketed in Japan by Schering-Plough KK and Bayer Yakuhin, 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 or “bad” cholesterol.

The drug will become available on June 11 following National Health Insurance Reimbursement price listing on June 8, the companies said. 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, 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. Schering-Plough, in collaboration with Merck, has developed and commercialized Zetia for lipid management in the US and the rest of the world (excluding Japan), where it is also marketed under the trade names Ezetrol and Zient.