The recombinant factor VIII (rfVIII) therapy Advate was initially developed by Baxter and then marketed by the pharmaceutical spin-off Baxalta, which is now part of Shire. Advate is the first third-generation rfVIII, and is a follow-on product to Shire’s Recombinate. Unlike its predecessor, Advate is produced using a manufacturing process free from the addition of animal- and human-derived proteins.
Advate was first approved in the US in 2003, and is now approved for a number of indications for the management of hemophilia, including the control and prevention of bleeding, perioperative management, and routine prophylaxis. To further support Advate, Shire launched the myPKFiT device that guides prophylactic dosing regimens for Advate based on the patient’s pharmacokinetic (PK) profile. It is the only registered software-based medical device for personalized hemophilia dosing. With only two blood samples, physicians can tailor the prophylaxis dosing regimen of Advate for each patient, while reducing the burden of repeated sampling that is otherwise required to profile a patient’s pharmacokinetics.
LIST OF FIGURES
9 Figure 1: Advate for hemophilia – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Advate for hemophilia
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Advate for hemophilia
13 Figure 4: Advate sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Advate drug profile
7 Table 2: Advate pivotal trial data in hemophilia
14 Table 3: Advate sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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