Galapagos NV (Euronext & NASDAQ: GLPG) reports that Gilead Sciences K.K. (Tokyo, Japan), Eisai Co., Ltd. (Tokyo, Japan) and EA Pharma Co., Ltd. (Tokyo, Japan) today announced the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW), of a second indication for Jyseleca (filgotinib), a once-daily, oral, JAK1 preferential inhibitor, for the treatment of patients with moderate-to-severe active ulcerative colitis (UC).
The approval of this second indication for Jyseleca in Japan is based on data from the randomized, double-blind, placebo-controlled phase 2b/3 SELECTION study. This study evaluated the efficacy and safety of Jyseleca for induction and maintenance of remission in patients with moderately to severely active ulcerative colitis who had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. The study showed that Jyseleca 200mg was well-tolerated and efficacious as induction and maintenance therapy with no new safety findings reported. Jyseleca was approved in Japan in September 2020 for the treatment of rheumatoid arthritis (RA), including the prevention of structural joint damage, in patients who had inadequate response to conventional therapies.
Gilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for product supply. Eisai will be responsible for product distribution, and together with EA Pharma, its subsidiary focused on gastrointestinal diseases, will jointly commercialize the medicine to make it available to physicians and patients across the country.
Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). Filgotinib is also approved and marketed as Jyseleca (200mg tablets) in the European Union, Great Britain and Japan for the treatment of adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The Great Britain Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc and the Northern Ireland Summary of Product Characteristics for filgotinib can be found at www.emcmedicines.com/en-GB/northernireland. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. A global Phase 3 program with filgotinib is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.
About the filgotinib collaboration
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos is responsible for the commercialization of filgotinib in Europe, while Gilead remains responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai.
Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.