Idelvion is a long-acting recombinant factor IX (rfIX) therapy developed by CSL Behring for hemophilia B. Idelvion is produced through the fusion of rfIX, manufactured in Chinese hamster ovary cells, to human recombinant albumin via a cleavable linker. The addition of albumin prolongs the half-life of rfIX until it is activated, at which point the albumin carrier is cleaved from the protein, allowing it to carry out its normal physiologic functions.
Idelvion was first approved in the US in March 2016 with a prophylactic dosing schedule of up to every 14 days. It has subsequently been approved in Japan and the EU, with global commercialization progressing through 2017.
LIST OF FIGURES
9 Figure 10: Datamonitor Healthcare’s drug assessment summary of Advate for hemophilia
10 Figure 11: Advate sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
11 Figure 12: AMT-061 for hemophilia – SWOT analysis
13 Figure 11: Adynovate for hemophilia – SWOT analysis
LIST OF TABLES
5 Table 1: Idelvion drug profile
14 Table 2: Idelvion sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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