Gilead's Jyseleca gains first approval, in Japan, for RA

US biotech major Gilead Sciences (Nasdaq: GILD) and Japan’s Eisai (TYO: 4523) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval of Jyseleca (filgotinib 200mg and 100mg tablets),

This is the first regulatory approval for filgotinib, a once-daily, oral, JAK1 preferential inhibitor for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.

Gilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for product supply of Jyseleca in Japan, while Eisai will be responsible for product distribution of Jyseleca in Japan in RA. The companies will jointly commercialize the medicine to make it available to physicians and patients across Japan.