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Gene therapy drugs step toward approval in Japan

Posted on: 14 November 2018, source: Nikkei Asia
Novartis has applied with Japanese authorities to have a gene therapy drug approved, a move that could give Japan at least two such drugs in the coming year, Nikkei has learned. The Switzerland-based pharmaceutical hopes to receive the all-clear in Japan for a neurological disorder treatment sometime next year. It has also applied for approval for the same drug in the U.S. and Europe. In the U.S., the drug is said to be prohibitively expensive -- as much as $4 million to $5 million per patient. The drug treats spinal muscular atrophy, and Novartis expects to be able to market the treatment as early as next year.