Afstyla is a single-chain recombinant factor VIII (rfVIII) product developed by CSL Behring to have a longer duration of action than standard rfVIII. Endogenously produced fVIII consists of a light chain and a heavy chain fused via a metal ion bridge. This connection can break, leaving the resulting fVIII chains inactive. However, in Afstyla, the light and heavy chains are covalently bonded, preventing dissociation and prolonging the half-life of the molecule.
However, Phase III trial results have shown that, when dosed individually, patients may still need to receive three doses each week in the prophylactic setting. This, in combination with a late market entry, will make it difficult for Afstyla to compete effectively with the already-established long-acting therapies Eloctate (rfVIII Fc fusion protein; Sanofi/Bioverativ) and Adynovate (PEGylated rfVIII; Shire).
LIST OF FIGURES
8 Figure 1: Afstyla for hemophilia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Afstyla for hemophilia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Afstyla for hemophilia
12 Figure 4: Afstyla sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES 5 Table 1: Afstyla drug profile
7 Table 2: Afstyla pivotal trial data in hemophilia
13 Table 3: Afstyla sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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