Biogen and Swedish Orphan Biovitrum co-developed Alprolix (recombinant factor IX [rfIX] Fc fusion protein) for the treatment of hemophilia B. The therapy is a recombinant protein consisting of a single fIX fused with the dimeric Fc region of immunoglobulin G-1. Fusion to the Fc region prolongs the half-life of fIX by binding to the neonatal Fc receptor, which delays lysosomal degradation of the protein and allows it to be recycled back into the bloodstream.
Alprolix became the first approved long-acting prophylactic therapy for hemophilia B in March 2014, offering a 10-day dosing interval. In February 2017, Biogen completed the separation of its global hemophilia business, resulting in the formation of Bioverativ as a spin-off company. In March 2018, Sanofi completed its acquisition of Bioverativ.
LIST OF FIGURES8 Figure 1: Alprolix for hemophilia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Alprolix for hemophilia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Alprolix for hemophilia
12 Figure 4: Alprolix sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES6 Table 1: Alprolix drug profile
7 Table 2: Alprolix pivotal trial data in hemophilia
13 Table 3: Alprolix sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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