8:38 AM
Mar 30, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

Japan approvals include Hemlibra, Shingrix Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc. (NASDAQ:FOLD).

Japan's Ministry of Health, Labour and Welfare (MHLW) approved Hemlibra to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A with Factor VIII inhibitors. Chugai, which is majority owned by Roche (SIX:ROG; OTCQX:RHHBY), initially developed Hemlibra and Roche opted into development of the product in 2014. The bispecific mAb that binds Factor IXa and Factor X is also approved in the U.S. and EU.

GSK said that both Japan's MHLW and the European Commission approved Shingrix for adults ages 50 and older....

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