ENGLISH
|
JAPANESE
|
CONNECT WITH US:
Home
About
Contact
Log in
*
Home
Press release
Mar 28, 2022 22:38 JST
Source:
Eisai
Eisai: Announcement About an Approval for Additional Indication of Jyseleca, JAK inhibitor
For the treatment of moderate to severe ulcerative colitis with inadequate response to conventional therapies
Approval of additional indication based on Phase IIb/III SELECTION data for patients with active moderate-to-severe ulcerative colitis
TOKYO, Mar 28, 2022 - (JCN Newswire) - Gilead Sciences K.K., Eisai Co., Ltd. and EA Pharma Co., Ltd. announced that Gilead acquired an approval of additional indication of Jyseleca (Generic name: Filgotinib, "Jyseleca"), Janus Kinase (JAK) inhibitor, for the treatment of patients with active moderate-to-severe ulcerative colitis in Japan. In September 2020, Jyseleca was approved for the treatment of patients with rheumatoid arthritis (including prevention of structural joint damage) who had an inadequate response to conventional therapies in Japan.
The approval of the additional indication is based on the data from Phase IIb/III SELECTION trial evaluating the efficacy and safety of Jyseleca in the induction and maintenance treatment of biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis. The trial comprises of two induction studies and one maintenance study. The trial showed the efficacy and safety profile of Jyseleca, and no new safety risks were identified.
Dr. Norifumi Hibi, Director of the Center for Advanced Treatment of Inflammatory Bowel Disease at Kitasato Institute Hospital, commented "Ulcerative colitis is a chronic inflammatory disease with sores and ulcers forms on the lining of the large intestine, and it accompanies by symptoms such as blood in stool, diarrhea and abdominal pain during the active stage. Despite advances in the treatment of ulcerative colitis, there is no curative treatment, and it is important to promptly induce remission and maintain remission to prevent relapse of inflammation. Because of persistent inflammation, there remains unmet medical needs as many patients still suffer from symptoms that affect their daily lives. With the approval for the additional indication, which showed the efficacy and safety in the induction and maintenance of remission, I am pleased that it provides a new treatment option for patients with unmet medical needs."
Dr. Mamoru Watanabe, Vice president of Tokyo Medical and Dental University, commented "Jyseleca is a new JAK inhibitor and in clinical studies, the efficacy and safety profile of Jyseleca for induction and maintenance of remission were demonstrated in patients with moderately to severely active ulcerative colitis who are biologic- naive and biologic-experienced. With the approval for the additional indication, I expect to see further progress in the treatment of ulcerative colitis."
Gilead and Eisai co-market Jyseleca for rheumatoid arthritis indication in Japan. Gilead and EA Pharma, which has been commissioned by Eisai, will co-promote the additional indication of ulcerative colitis. Gilead, Eisai and EA Pharma will expand the therapeutic options for ulcerative colitis and strive to further contribute to improving the QOL of patients and their families through Jyseleca.
For more information, visit
https://www.eisai.com/news/2022/news202223.html
.
Source: Eisai
Sectors: BioTech
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Latest Release
Four-strong TOYOTA GAZOO Racing squad to push for more Portugal success
May 02, 2024 18:05 JST
Spectacular Spa awaits TOYOTA GAZOO Racing
May 02, 2024 17:46 JST
Q&M Dental Enhances Digital Capabilities by Integrating Align Technology's Newest iTero Lumina(TM) Intraoral Scanner Across Dental Clinics in Singapore
May 02, 2024 11:00 JST
Sumitomo Metal Mining and Mitsubishi Corporation to Participate in Kalgoorlie Nickel Project - Goongarrie Hub
Apr 30, 2024 19:08 JST
New Immuno-Oncology Research Project in Partnership With Merck Starts at the BioMed X Institute in Heidelberg
Apr 30, 2024 18:00 JST
SPARX Group Establishes Space Frontiers Second Fund
Apr 29, 2024 18:49 JST
MHI Establishes Local Subsidiary "Mitsubishi Heavy Industries Vietnam"
Apr 29, 2024 18:00 JST
POSCO Future M and Honda Reach Basic Agreement on Collaboration for Production of Cathode Materials for Automotive Batteries in Canada
Apr 29, 2024 14:25 JST
Honda Plans to Establish Comprehensive Electric Vehicle Value Chain in Ontario, Canada
Apr 29, 2024 14:16 JST
JCB enables JCB Contactless acceptance at Taichung MRT in Taiwan
Apr 26, 2024 10:00 JST
Mazda Production and Sales Results for March 2024 and for April 2023 through March 2024
Apr 25, 2024 18:21 JST
MHI Begins Operation of SOEC Test Module the Next-Generation High-Efficiency Hydrogen Production Technology at Takasago Hydrogen Park
Apr 25, 2024 17:45 JST
GAC Honda to Begin Sales of All-new e:NP2, the Second Model of e:N Series
Apr 25, 2024 16:50 JST
Toyota Exhibiting at Beijing Motor Show 2024
Apr 25, 2024 16:25 JST
Honda Reaches Basic Agreement with Asahi Kasei on Collaboration for Production of Battery Separators for Automotive Batteries in Canada
Apr 25, 2024 11:10 JST
UNIQLO Sponsors KAWS + Warhol Exhibition Tour, Starting in Pittsburgh
Apr 25, 2024 09:00 JST
Mitsubishi Power Begins Commercial Operation of Seventh M701JAC Gas Turbine in Thailand GTCC Project; Achieves 75,000 AOH To-Date
Apr 24, 2024 17:19 JST
MC and Denka Sign J/V Agreement in Fullerene Business
Apr 24, 2024 17:02 JST
Mitsubishi Motors Posts Record Sales in the Philippines in FY2023
Apr 24, 2024 13:56 JST
NEC Develops High-speed Generative AI Large Language Models (LLM) with World-class Performance
Apr 24, 2024 13:25 JST
More Latest Release >>
Related Release
Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)
4/18/2024 10:53:00 AM JST
Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan
4/17/2024 4:17:00 PM JST
French Sales Subsidiary Eisai S.A.S. to Divest Rights for Loxapac And Parkinane LP to CNX Therapeutics
4/3/2024 4:24:00 PM JST
Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA
4/1/2024 9:39:00 AM JST
Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical
3/29/2024 3:51:00 PM JST
Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture
3/29/2024 3:19:00 PM JST
Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024
3/29/2024 2:32:00 PM JST
Lifenet and Eisai Co-Develop Dementia Insurance "be"
3/21/2024 5:36:00 PM JST
Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace
3/21/2024 4:10:00 PM JST
Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients
3/6/2024 5:47:00 PM JST
More Press release >>