Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) announced today the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca (filgotinib 200 mg and 100 mg tablets), an investigational, once-daily, oral, selective JAK1 inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe.
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The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials, involving a broad range of patients, met their primary endpoints. In the trials, filgotinib consistently achieved ACR20/50/70 and other relevant treatment targets, such as DAS28(CRP)<2.6. Filgotinib also inhibited the progression of structural joint damage assessed by modified total Sharp score (mTSS) compared with placebo. Across the FINCH and DARWIN trials, once-daily filgotinib demonstrated a consistent clinical safety profile when administered as monotherapy or in combination with methotrexate (MTX). Rates of serious infections and herpes zoster were generally similar to adalimumab and MTX, while rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) were infrequently reported.
The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to authorize medicines in the 27 countries of the European Union, Norway, Iceland, Liechtenstein and UK. A Commission decision is expected in the third quarter of 2020.
Filgotinib is an investigational agent and is not approved for use by any regulatory authority.
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety of filgotinib 100 mg and 200 mg once-daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 was a 52‑week, randomized, placebo- and adalimumab-controlled trial in combination with MTX, enrolling 1,759 adult patients with moderately to severely active RA who had inadequate response to MTX. The primary endpoint in FINCH 1 was ACR20 at Week 12. The trial included radiographic assessment at Weeks 24 and 52. FINCH 2 was a global, 24-week randomized, double-blind, placebo-controlled, Phase 3 study evaluating filgotinib on a background of conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) among 449 adult patients with moderately to severely active RA who had not adequately responded to biologic DMARDs (bDMARDs). The primary endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a 52‑week, randomized trial in 1,252 MTX-naïve patients to evaluate filgotinib 200 mg alone and filgotinib 100 mg or 200 mg combined with MTX versus MTX alone in MTX-naïve patients. The primary endpoint in FINCH 3 was ACR20 at Week 24. The trial included radiographic assessment at Weeks 24 and 52. Filgotinib is an oral, selective JAK inhibitor with preferential activity for JAK1 and JAK 1/3 signaling.