Mozobil drug lag reviewed in Japan

As part of its mandate to eliminate the lag between medicines approved in Japan and other countries, a subcommittee of the Ministry of Health,  Labor and Welfare's Study Committee on the Use of Unapproved Drugs has  been asked to consider whether the development of US biotechnology firm  Genzyme's Mozobil (plerixafor) should be encouraged. The drug is  intended to enhance mobilization of hematopoietic stem cells for  collection and subsequent autologous transplantation in patients with  lymphoma and multiple myeloma. There are no similar products available  in Japan.

Moreover, academic societies and patient organizations have no pending  requests for development, having discussed eight new compounds that  were approved in the USA, the UK, France and Germany between last  December and this January.

Since the committee was established in January 2005, the number of  products approved went from zero to 20 among 44 that were discussed by  the panel as of end-February. 11 and eight agents, respectively, are  under clinical planning and in trials. However, developers for three  compounds are still being sought. Of 44 drugs, 22 are for cancer, 11 are  pediatric agents for congenital illnesses and 11 are for other  diseases.