Gilead Sciences Inc.'s (GILD) Jyseleca, available as 100 mg and 200 mg film-coated tablets, has been approved in Japan for the treatment of rheumatoid arthritis in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.
It is estimated that there are 600,000 to 1 million people with rheumatoid arthritis across Japan.
Gilead and Eisai Co., Ltd. (ESALY.PK) have an agreement for the distribution and co-promotion of Jyseleca in Japan. As per this agreement, 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 rheumatoid arthritis.
The two companies will jointly commercialize the medicine to make it available to physicians and patients across Japan.
Last month, the FDA refused to approve Jyseleca raising concerns about the overall risk-benefit profile of the 200 mg dose and had requested the company to present additional data before it could be approved.
Jyseleca won the backing of the European Medicines Agency's panel in July of this year and a final decision of the European Commission is expected this month.
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