LR769 is a recombinant factor VIIa (rfVIIa) therapy in development by LFB for patients with hemophilia A or B with inhibitors. Unlike the marketed rfVIIa product NovoSeven (Novo Nordisk), which is produced in baby hamster kidney cells, LR769 is produced in mammalian milk via LFB’s rPRO technology. This process allows for much higher protein expression levels and therefore provides significant cost efficiency.
LR769 was filed for regulatory approval in the US in January 2017. If approved, HEMA Biologics will have full commercialization rights in North America.
TABLE OF CONTENTS
4 Drug Overview
5 Product Profiles
5 LR769 : Hemophilia
8 Table 2: LR769 Phase III trials in hemophilia
LIST OF FIGURES 8 Figure 41: Datamonitor Healthcare’s drug assessment summary of LR769 for hemophilia
9 Figure 34: Datamonitor Healthcare’s drug assessment summary of Idelvion for hemophilia
LIST OF TABLES
6 Table 1: LR769 drug profile
12 Table 34: Idelvion sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
12 Table 3: LR769 sales for hemophilia in the US ($m), 2016–25
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