Xyntha (Pfizer) is a B-domain deleted recombinant factor VIII (rfVIII) product, approved in the US and EU for the prevention and treatment of bleeding episodes in patients with hemophilia A. Xyntha is produced through a similar manufacturing process as its predecessor, ReFacto (rfVIII). However, the process has been modified to allow for the elimination of animal- and human-derived proteins, producing a purer recombinant factor product. Wyeth submitted a Biologics License Application for Xyntha in 2007 based on these manufacturing modifications, which was approved in 2008. Xyntha is marketed as ReFacto AF in Europe.
LIST OF FIGURES8 Figure 33: Eloctate for hemophilia – SWOT analysis
9 Figure 34: Datamonitor Healthcare’s drug assessment summary of Eloctate for hemophilia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Xyntha for hemophilia
12 Figure 4: Xyntha sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES5 Table 1: Xyntha drug profile
7 Table 2: Xyntha pivotal trial data in hemophilia
13 Table 3: Xyntha sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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