Roche: CHMP recommends approval of Hemlibra

(CercleFinance.com) - Roche has announced that the CHMP of the European Medicines Agency has adopted a positive opinion, in the European Union, for its Hemlibra (emicizumab) in severe hemophilia A without factor VIII inhibitors.


This favourable opinion is based on the results of pivotal Haven 3 and 4 studies, that showed that Hemlibra "led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis, and compared to prior treatment with factor VIII prophylaxis in a prospective intra-patient comparison."


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