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Japan's MHLW OKs Shire's Elaprase.(Shire Pharmaceuticals Group PLC)(Ministry of Health ,Labor and Welfare)(Brief article)
UK drugmaker Shire says that Japan's Ministry of Health, Labor and Welfare has approved its product Elaprase (idursulfase) for the treatment of Hunter syndrome. The decision means that the drug, a human enzyme replacement therapy, has gained regulatory clearance in 34 countries worldwide since the US Food and Drug Administration first approved it last year (Marketletter July 31, 2006).
Shire president Sylvie Gregoire said that the decision is another step towards making the drug available to Hunter syndrome patients worldwide. She added that the firm greatly appreciated the commitment of Japanese patients to the drug, some of whom ...
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