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Gilead Sciences : Filgotinib Shows Sustained Efficacy In Studies On Rheumatoid Arthritis

Gilead Sciences Inc. (GILD) and Galapagos NV (GLPG) said that data from Phase 3 FINCH 1 and FINCH 3 studies of filgotinib demonstrated sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across rheumatoid arthritis patient populations.

The study of filgotinib is an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis.

Filgotinib 200 mg and 100 mg demonstrated a consistent safety profile in this study of MTX-IR patients, and no new safety signals were detected through Week 52. There were five deaths reported prior to Week 24; two patients were in the placebo group, two were in the filgotinib 200 mg group and one was in the filgotinib 100 mg group.

Four deaths were reported between Weeks 24 and 52; two treated with filgotinib 200 mg, one in the adalimumab group, and one in the placebo group. Adverse events of interest including serious infections, herpes zoster, venous thromboembolism (VTE) and major adverse cardiovascular events (MACE) were infrequent and balanced across treatment groups.

The company noted that integrated safety Analysis from the Phase 3 FINCH and Phase 2 DARWIN Programs informed long-term safety profile of filgotinib in rheumatoid arthritis.

Gilead and Galapagos are collaborative partners in the global development and commercialization of filgotinib in rheumatoid arthritis, and other inflammatory indications.

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