Vonvendi (Shire) became the first recombinant von Willebrand factor (rVWF) therapy approved in the US in December 2015. Vonvendi is produced via Chinese hamster ovary cells without the addition of human or animal raw materials in the cell culture or final formulation.
Vonvendi is approved for the on-demand treatment and control of bleeding episodes in adults with von Willebrand disease. Shire has also conducted an additional study that will expand the product’s US label to include perioperative management, as well as supporting its June 2017 regulatory filing in the EU, where it will be marketed as Veyvondi. Shire added Vonvendi to its portfolio in its 2015 acquisition of the Baxter spin-off, Baxalta.
Although the market opportunity is smaller than that for hemophilia A or B products, the availability of Vonvendi may allow for a faster growth rate of this market, especially if Shire is able to demonstrate that its product is an appropriate prophylactic therapy. However, Vonvendi’s high treatment cost in this setting, in addition to the reduced severity of bleeds and complications, will constrain its use as a preventive drug.
LIST OF FIGURES
8 Figure 55: Datamonitor Healthcare’s drug assessment summary of Rixubis for hemophilia
9 Figure 53: Datamonitor Healthcare’s drug assessment summary of Vonvendi for hemophilia
10 Figure 13: Datamonitor Healthcare’s drug assessment summary of Adynovate for hemophilia
LIST OF TABLES 6 Table 1: Vonvendi drug profile
61 Table 10: Advate sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
13 Table 3: Vonvendi sales for hemophilia across the US and five major EU markets, by country ($m), 2016–25
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