-- Integrated Safety Analysis from the Phase 3 FINCH and Phase 2 DARWIN Programs Informs the Long-Term Safety Profile of Filgotinib in RA --

-- Data Presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020 --

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced Week 52 results from the Phase 3 FINCH 1 and FINCH 3 studies of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis (RA). The data demonstrate sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations. The new data are among 15 abstracts on filgotinib in RA that will be presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.

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“Many people with RA struggle with uncontrolled symptoms that affect their daily lives. We are working to develop effective and well-tolerated treatment options that will make a difference in the lives of patients,” said Mark Genovese, MD, Senior Vice President, Inflammation, Gilead Sciences. “These data add to the body of evidence supporting filgotinib as a potential treatment option for a range of RA patients.”

“After more than 4,544 patient-years’ exposure thus far, the FINCH and DARWIN programs continue to show that filgotinib has a consistent efficacy and safety profile and has the potential to help more people living with RA achieve meaningful symptom control,” said Walid Abi-Saab, MD, Chief Medical Officer at Galapagos.

FINCH 1 - 52-Week Data from Phase 3 Study in Patients with Inadequate Response to Methotrexate (Poster #0198)1

The FINCH 1 program evaluated filgotinib versus placebo or adalimumab, on a stable background dose of methotrexate in patients with moderately to severely active RA who had prior inadequate response to methotrexate (MTX-IR). Patients were randomized to receive filgotinib 200 mg once daily (n=475), filgotinib 100 mg once daily (n=480), adalimumab 40 mg bi-weekly (n=325) or matching placebo (n=475).

As previously reported, the filgotinib 200 mg group met the primary study endpoint evaluating the proportion of patients who achieved American College of Rheumatology Criteria of at least a 20 percent improvement in the number of tender and swollen joints (ACR20) at Week 12 versus placebo. Filgotinib was superior to placebo in all secondary endpoints pertaining to signs and symptoms of RA, physical function and structural damage.

The majority of patients in FINCH 1 (80.7 percent, n=1,417/1,755) completed 52 weeks of treatment with study drug. Both doses of filgotinib showed sustained efficacy in primary and secondary outcome measures at Week 52. In addition, a greater proportion of patients treated with filgotinib 200 mg achieved low disease activity (DAS28(CRP) ≤3.2) and clinical remission (DAS28(CRP)