Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.
Approximately 600,000 to 1m people are living with RA across Japan, and despite available options, many still do not experience disease remission. In the global Phase 3 FINCH studies, filgotinib demonstrated durable efficacy and safety results across multiple RA patient populations, including in people with prior inadequate response to methotrexate treatment, those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve.
Global studies investigating filgotinib in additional diseases are also underway, including the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn's disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in small bowel and fistulizing Crohn's disease.
Gilead and Galapagos NV (Mechelen, Belgium) have entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. Filgotinib is an investigational drug whose efficacy and safety have not been established.
Filgotinib is pending regulatory approval in Japan, Europe and the United States, based on global Phase 3 trials evaluating its efficacy and tolerability.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.
The company has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
Eisai Co., Ltd. is a global research and development-based pharmaceutical company headquartered in Japan.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Ono partners with Shattuck Labs for bifunctional fusion proteins
Artax Biopharma doses first subject in AX-158 Phase 2a psoriasis trial
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
BioSenic expands patent coverage for ATO therapeutic platform
Celltrion USA submits CT-P47 Biologics License Application to FDA
NS Pharma's NS-229 receives European Commission orphan drug designation
Kyverna Therapeutics' KYV-101 granted US FDA fast track designation
InnoCare Pharma receives U.S. FDA clearance for ICP-248 clinical trial
Biosenic finalises agreement with Phebra for oral arsenic troxide development
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Allorion Therapeutics signs exclusive option and global license agreement with AstraZeneca