Nov 18, 2020 20:00 JST

Source: Eisai

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

Copyright ©2026 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Marketing Authorization Application for In-house Developed Insomnia Drug Lemborexant Accepted for Evaluation by European Medicines Agency (EMA)
July 17 2026 23:24 JST
 
LEQEMBI(R) Real-World LEADER Study Presented at AAIC(R) 2026 Finds Over 75% of Early Alzheimer's Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of Treatment
July 15 2026 23:18 JST
 
FDA Approves LEQEMBI IQLIK(R) (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer's Disease
July 15 2026 22:51 JST
 
Eisai Presents Latest Findings Showed Etalanetug Reduced Alzheimer's Disease Tau Tangle-Specific Plasma Biomarker MTBR-tau243 at Alzheimer's Association International Conference(R) (AAIC(R)) 2026
July 15 2026 22:21 JST
 
LEQEMBI(R) Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer's Disease Presented at the Alzheimer's Association International Conference(R) (AAIC(R)) 2026
July 13 2026 23:06 JST
 
Eisai to Showcase Alzheimer's Disease Portfolio with More Than 50 Presentations at the Alzheimer's Association International Conference(R) 2026 (AAIC(R))
July 02 2026 21:45 JST
 
UCL and Eisai renew partnership to accelerate treatments for neurodegenerative diseases
July 02 2026 21:01 JST
 
Eisai Announces Strategic Investment Supported by the UK Government's LSIMF
June 17 2026 12:28 JST
 
Eisai Deepens Body of Clinical Evidence for LENVIMA(R) (Lenvatinib) Across Established Indications at ASCO 2026
May 21 2026 23:23 JST
 
Merck & Co., Inc., Rahway, NJ, USA and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
April 21 2026 19:52 JST
 
More Press release >>

Latest Press Release


More Latest Release >>