Policy & Regulation
Gilead and Eisai announce Japanese approval of Jyseleca rheumatoid arthritis treatment
25 September 2020 -

US-based Gilead Sciences Inc (Nasdaq: GILD) and Japan-based Eisai Co Ltd (Tokyo, Japan) announced on Friday that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead KK (Tokyo, Japan) regulatory approval of Jyseleca(R) (filgotinib 200mg and 100mg tablets).

The product is 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. The approval in Japan is based on robust clinical trial results from the global FINCH Phase 3 and DARWIN Phase 2 programs.

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 commercialise the medicine to make it available to physicians and patients across Japan.

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