Eloctate (Sanofi/Bioverativ) is a fusion protein consisting of a B-domain deleted factor VIII (fVIII) protein fused to the dimeric human Fc region of immunoglobulin G-1. Fusion to the Fc region prolongs the half-life of fVIII by binding to the neonatal Fc receptor, which delays lysosomal degradation of the protein and allows it to be recycled back into the bloodstream.
Eloctate is the first fourth-generation recombinant product, produced by a human embryonic kidney cell line, eliminating a potential source of non-human mammalian proteins with antigenic potential. It was developed in a collaboration between Biogen and Swedish Orphan Biovitrum, and gained first approval in June 2014. 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 FIGURES
8 Figure 1: Eloctate for hemophilia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Eloctate for hemophilia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Eloctate for hemophilia
12 Figure 4: Eloctate sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES 6 Table 1: Eloctate drug profile
7 Table 2: Eloctate pivotal trial data in hemophilia
13 Table 3: Eloctate sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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