Hemlibra is an anti-factor IXa/X bispecific antibody, developed by Roche as a new treatment option for hemophilia A patients. Hemlibra binds to both factor IXa and factor X, placing both proteins in the correct spatial positions and promoting activation of factor X. By doing so, the drug mimics the normal function of factor VIII and demonstrates hemostatic activity in hemophilia A patients with and without inhibitors.
Roche secured its first approval for Hemlibra as a treatment option for hemophilia A patients with inhibitors in November 2017 in the US. The drug is also undergoing regulatory review outside of the US, and is separately being developed for hemophilia A patients without inhibitors.
LIST OF FIGURES 9 Figure 13: Datamonitor Healthcare’s drug assessment summary of Afstyla for hemophilia
9 Figure 48: Datamonitor Healthcare’s drug assessment summary of Rebinyn for hemophilia
LIST OF TABLES
6 Table 1: Hemlibra drug profile
13 Table 59: Rixubis pivotal trial data in hemophilia
14 Table 3: Hemlibra sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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