Japan's Ministry of Health, Labour and Welfare grants approval for Actelion's 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."
Most read news
Other news from the department research and development
Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.