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Thursday, February 9, 2023

Galapagos misses on Phase 3 in Crohn's

 

  • The two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10

  • In the maintenance phase, filgotinib 200mg once daily achieved the co-primary endpoints of clinical remission and endoscopic response at Week 58

  • The safety findings were generally consistent with the known profile of filgotinib in rheumatoid arthritis (RA) and ulcerative colitis (UC)

  • Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline data

  • Galapagos remains fully committed to filgotinib, a JAK1 preferential inhibitor orally administered once daily, and its approved indications, RA and UC, and is on track to start a Phase 3 trial in axial spondyloarthritis (AxSpA) later this year

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