European Commission Grants Marketing Authorization for Jyseleca® ▼ (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis
Gilead Sciences and Galapagos NV today announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).
RA is a chronic, progressive, systemic, inflammatory disease that can lead to significant and irreversible joint destruction, pain and functional impairment. Almost 3 million people in Europe are living with RA, many of whom do not achieve long-term symptom control, which can lead to more frequent symptom flares and disease progression and can significantly impact their quality of life.
The EC's decision is supported by data from over 3,500 patients treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN programs.6 In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX.