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Biogen gets Chinese approval for Spinraza

February 28, 2019 9:59 PM UTC

China's National Medical Products Administration (NMPA) approved spinal muscular atrophy therapy Spinraza nusinersen from Biogen Inc. (NASDAQ:BIIB) on Thursday. The therapy is approved to treat 5q SMA, which Biogen said accounts for 95% of SMA cases.

Biogen said Spinraza was evaluated under Priority Review as a clinically urgent drug that has been approved overseas for a rare disease. SMA is included on China's national list of rare diseases, which is intended to support diagnosis and treatment of such conditions (see "China Rare Disease List Could Promote R&D, Regulatory Filings")...

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