CHMP backs Genentech's Hemlibra for hemophilia A

EMA’s CHMP 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...