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.
https://seekingalpha.com/news/3617242-gileads-jyseleca-okd-in-japan-for-rheumatoid-arthritis
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