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CHMP backs Hemlibra, Shingrix, Lamzede

January 26, 2018 11:58 PM UTC

CHMP announced a spate of opinions Friday, including positive recommendations for Hemlibra emicizumab-kxwh, Shingrix herpes zoster vaccine and Lamzede velmanase alfa, as well as the anticipated negative opinion for Raxone idebenone.

The committee recommended approval of Hemlibra from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for routine prophylaxis of bleeding episodes in patients with hemophilia A with factor VIII inhibitors. The bispecific mAb that binds Factor IXa and Factor X (FX) was reviewed under accelerated assessment. It is already approved in the U.S. for the indication...