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ARTICLE | Clinical News

FDA approves Roche's Hemlibra for hemophilia without inhibitors

October 11, 2018 11:06 PM UTC

FDA approved an sBLA for Hemlibra emicizumab-kxwh from Roche (SIX:ROG; OTCQX:RHHBY) to reduce the frequency of bleeding episodes in adults and children with hemophilia A without Factor VIII inhibitors. The company said it is now the only subcutaneous hemophilia A prophylactic for patients without Factor VIII inhibitors that can be dosed on multiple schedules, including once weekly, every two weeks or every four weeks.

The sBLA was under Priority Review. The drug, a bispecific mAb that binds Factor IXa and Factor X, has FDA breakthrough therapy status in the indication (see "Hemlibra Gets Priority Review")...