- Japan's Ministry of Health, Labor and Welfare has approved Gilead's (NASDAQ:GILD) Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily oral JAK1 inhibitor, for the treatment of rheumatoid arthritis (RA) patients who did not respond adequately to conventional therapies.
- Gilead will hold the marketing authorization of Jyseleca in Japan and supply the product, while Eisai (OTCPK:ESALF) will manage distribution.
- Gilead is developing Jyseleca in collaboration with Galapagos (NASDAQ:GLPG).
- Last month, Galapagos and Gilead announced FDA CRL for filgotinib for RA as the agency requested for more data and review period extended into 2021.