Eisai: Jyseleca (Filgotinib) for Rheumatoid Arthritis Launches in Japan

A once-daily, oral, JAK inhibitor for the treatment of rheumatoid arthritis in patients who have had an inadequate response to conventional therapies

TOKYO, Nov 18, 2020 - (JCN Newswire) - Gilead Sciences K.K. and Eisai Co., Ltd. today announced that Jyseleca (filgotinib maleate 200 mg and 100 mg tablets), a new once-daily, oral, JAK (Janus kinase) inhibitor that preferentially inhibits JAK1, will be launched in Japan on November 18 for the treatment of rheumatoid arthritis (RA), with prior regulatory approval by the Japanese Ministry of Health, Labour and Welfare.

Jyseleca is indicated for RA (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. The therapy has received approval in Japan and Europe.

Based on a co-promotion agreement entered into by Gilead and Eisai in December 2019, Gilead will hold the marketing authorization of Jyseleca, while Eisai will be responsible for product distribution of Jyseleca in Japan. The companies will collaborate in product information provision activities in Japan.

"It is estimated that approximately 600,000 to 1 million people1 are living with RA across Japan," said Luc Hermans, MD, President and Representative Director, Gilead Sciences, K.K. "While RA treatment is advancing, many patients still do not experience sufficient disease remission, and many unmet medical needs remain. Gilead and Eisai are committed to delivering the new treatment option Jyseleca and supporting RA patients in Japan."

"Eisai has extensive clinical development and commercialization experience in RA and has established a solid RA franchise in Japan," said Hidenori Yabune, President of Eisai Japan, Senior Vice President, Eisai. "With the launch of Jyseleca, we will make further contributions to meet the diverse needs of RA patients and improve their QOL (quality of life)."

Multiple clinical trials are being conducted to investigate the potential role of filgotinib in a variety of diseases, including the Phase 3 SELECTION program in ulcerative colitis and the Phase 3 DIVERSITY program in Crohn?s disease. The safety and efficacy of filgotinib has not been demonstrated for these uses.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more information on Gilead Sciences, please visit the company?s website at www.gilead.com(New Window).

For more information on Gilead Sciences K.K., please visit the company?s website at https://www.gilead.co.jp/

Source: Eisai
Sectors: Healthcare & Pharm