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Japan's Ministry of Health, Labour and Welfare grants approval for Actelion's miglustat for the treatment of Niemann-Pick type C disease
04-04-2012: Actelion Ltd announced that Japan's Ministry of Health, Labour and Welfare has granted approval for miglustat for the treatment of Niemann-Pick type C disease.
The approval was based on the data generated for the first approval of miglustat in this indication in the European Union, as well as data specifically generated for the submission to the Japanese Health Authorities.
Satoshi Tanaka, President of Actelion Japan and South Korea commented: "I am very proud to have achieved this successful approval. Our organization has been able to generate the additional clinical data required for the first approval of miglustat in Japan, successfully registered the drug in this orphan disease and we are looking forward to bringing the first therapy to patients with this devastating neurodegenerative disease."
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