Japan's development of Xenazine urged

12 January 2009

The Study Committee on the Use of Unapproved Drugs within the Japanese Ministry of Health, Labor and Welfare urged the MHLW to call on the  relevant the parties to develop domestically US drug company Prestwick  Pharmaceutical's Xenazine (tetrabenazine), a treatment for Huntington's  disease. The issue has been discussed by its working group since the  last meeting of the panel was held in September 2008.

There is no treatment alternative for the disease on the Japanese  market, although dopamine receptor blockers, including haloperidol,  sulpiride and tiapride, as well as reserpin, a peripheral sympathetic  blocking agent, have been prescribed off-label in Japan. Xenazine has  been approved in 10 countries, such as the USA, some European Union  nations, Canada, Australia and New Zealand. The MHLW will seek out  companies willing to develop the drug because Prestwick has no Japanese  subsidiary, representative or agent.

The study panel, which was established to eliminate the so-called  "drug-lag," between Japan and other countries, has reduced the number of  compounds awaiting clinical trials from 29 to eight, resulting in  increasing "approved drugs" from zero to 19 between its first meeting  in January 2005 and that in December 2008.

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