CSL627
Publisher: Datamonitor Healthcare
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Drug Overview
CSL627 is a single-chain rfVIII product in development for hemophilia A. 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 CSL627, the light and heavy chains are
covalently bonded, preventing dissociation and prolonging the half-life of the molecule (Zollner et al.,
2014).
Analyst Outlook
Developed by CSL Behring, CSL627 is a single-chain recombinant factor VIII (rfVIII) designed to have
an extended half-life in comparison to standard rfVIII treatments. However, Phase III trial results have
shown that, when dosed individually, the majority of patients need to receive three doses of CSL627
weekly in the prophylactic setting. This, in combination with its market timing, will make it difficult
for the drug to compete effectively with first-to-market long-acting therapy Eloctate (rfVIII Fc fusion
protein; Biogen/Swedish Orphan Biovitrum).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 CSL627 : Hemophilia
LIST OF FIGURES
8 Figure 1: CSL627 for hemophilia A – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of CSL627 in hemophilia A
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of CSL627 in hemophilia A
LIST OF TABLES
4 Table 1: CSL627 drug profile
6 Table 2: CSL627 Phase III data in hemophilia A
8 Table 3: CSL627 Phase III trials in hemophilia A
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