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MHLW Approves MPS VI Drug Naglzayme

This article was originally published in PharmAsia News

Executive Summary

Osaka-based Anges MG announced that mucopolysaccharidosis VI drug Naglazyme (galsulfase) received manufacturing and marketing approval by Japan's Ministry of Health, Labor and Welfare March 28, three days after it cleared MHLW's drug review panel. The ministry considers Naglazyme the only effective treatment for MPS VI. A severe and progressive genetic disease, MPS is caused by an enzyme deficiency, which leads to progressive organ system dysfunction. Naglazyme has been available in Europe and the U.S and was designated as an orphan drug last June. The NHI price listing will take place in April 18. Anges MG obtained developing and marketing rights in Japan from California-based BioMarin. (Click here for more - Japanese language

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