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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze