European Commission approves Jyseleca to treat adults with moderate to severe rheumatoid arthritis.- Gilead Sciences + Galapagos NV.

Gilead Sciences, Inc.and Galapagos NV announced that the European Commission (EC) has granted marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets), 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). The EC’s decision is supported by data from more than 3,500 patients treated with Jyseleca across the Phase III FINCH and Phase II DARWIN programs. In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX. In patients who had an inadequate response to MTX, treatment with Jyseleca plus MTX achieved statistically significant inhibition of progression of structural joint damage compared with placebo plus MTX, as assessed using the modified Total Sharp Score (mTSS) at Week 24. In the DARWIN 3 Phase II, open-label, long-term extension study, durable ACR20/50/70 responses were maintained for up to three years in patients who received Jyseleca 200 mg as monotherapy or with MTX.