Japan's MHLW proposes "drug lag" solution

5 February 2007

The early development of two drugs in Japan has been recommended to their relevant pharmaceutical manufacturers by the Study Committee on Usage of Unapproved Drugs within the Japanese Ministry of Health, Labor and Welfare.

These are: Bryan Corp's Aclerosol Intrapleural Aerosol (sterile talc powder 4g), a treatment for malignant pleural effusion, which has been approved in the USA and the European Union; US affiliate of Germany's Schering AG, Berlex' Campath (alemtuzumab), a treatment for B-cell chronic lymphocytic leukemia (CLL), which has been approved in the USA and the European Union.

Concerning the latter drug, the clinical development for the indication for T-cell lymphoma was also urged in addition to CLL because of the presence, in Japan, of relatively large numbers of patients with T-cell lymphoma compared to other countries.

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