BAX 817 is a recombinant factor VIIa (rfVIIa) therapy in development by Baxalta for patients with hemophilia A or B with inhibitors. FVIIa therapy can circumvent the need for fVIII and fIX in the coagulation cascade by directly activating factor X, thereby increasing thrombin levels and formation of fibrin clots.
The launch of Baxalta’s recombinant factor VIIa (rfVIIa) therapy BAX 817 will allow the company to address a broader range of hemophilia patients with inhibitors. If approved, the drug will be available for patients who are refractory to FEIBA (factor eight inhibitor bypassing activity; Baxalta), or who choose to use an rfVIIa product instead. Although this expands Baxalta’s target patient population, it will be difficult for BAX 817 to gain substantial market penetration due to its undifferentiated clinical profile in comparison to long-standing rfVIIa treatment NovoSeven (Novo Nordisk).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 BAX 817 : Hemophilia
LIST OF FIGURES
6 Figure 1: BAX 817 for hemophilia with inhibitors – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary of BAX 817 in hemophilia with
8 Figure 3: Datamonitor Healthcare’s drug assessment summary of BAX 817 in hemophilia with
LIST OF TABLES
4 Table 1: BAX 817 drug profile
5 Table 2: BAX 817 Phase III data in hemophilia with inhibitors
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