Drug Overview
Filgotinib (Galapagos/Gilead) is an orally available Janus kinase (JAK)-1 inhibitor. The drug inhibits the JAK-1 receptor required for signal transduction upon binding of cytokines at the cell surface. This, in turn, blocks the JAK/STAT signaling pathway required to activate gene expression of various immune cells. Filgotinib is in late-phase development in Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 filgotinib : Rheumatoid arthritis (RA)
16 filgotinib : Ulcerative colitis
23 filgotinib : Crohn’s disease
LIST OF FIGURES
11 Figure 1: Filgotinib for rheumatoid arthritis – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of filgotinib in rheumatoid arthritis
13 Figure 3: Datamonitor Healthcare’s drug assessment summary of filgotinib in rheumatoid arthritis
19 Figure 4: Filgotinib for ulcerative colitis – SWOT analysis
20 Figure 5: Datamonitor Healthcare’s drug assessment summary of filgotinib for ulcerative colitis
21 Figure 6: Datamonitor Healthcare’s drug assessment summary of filgotinib for ulcerative colitis
29 Figure 7: Filgotinib for Crohn’s disease – SWOT analysis
30 Figure 8: Datamonitor Healthcare’s drug assessment summary of filgotinib in Crohn’s disease
31 Figure 9: Datamonitor Healthcare’s drug assessment summary of filgotinib in Crohn’s disease
33 Figure 10: Filgotinib sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Filgotinib drug profile
8 Table 2: Filgotinib Phase III trials in rheumatoid arthritis
9 Table 3: Primary endpoint for filgotinib at week 12 in the Phase IIb DARWIN 2 trial
10 Table 4: Efficacy responses with filgotinib after 12 and 24 weeks of treatment in the DARWIN 1 trial (%)
17 Table 5: Filgotinib drug profile
18 Table 6: Filgotinib Phase III trials in ulcerative colitis
23 Table 7: Filgotinib drug profile
25 Table 8: Ongoing pivotal Phase III trials of filgotinib in Crohn’s disease
28 Table 9: Phase II trial data of filgotinib in Crohn’s disease
34 Table 10: Filgotinib sales for Crohn’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25