Galapagos NV announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year.
The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately to severely active UC who have failed conventional therapy or biologics. SELECTION comprised two placebo-controlled induction studies, one in biologic-naive patients and the other in biologic-experienced patients, followed by a 47-week maintenance study for those who responded to filgotinib after 10 weeks. Responders to placebo continued on blinded placebo during the maintenance phase. The trial was recently published in The Lancet (1).
Dr Walid Abi-Saab, Chief Medical Officer at Galapagos, said: “Ulcerative colitis can have significant and profound effects on the people who suffer with the condition. Persistent inflammation and uncontrolled disease mean patients may experience debilitating relapses, may need increasing doses of steroids and in some instances may require surgery, which impacts them not only physically, but also psychologically. Today’s decision brings us one step closer to providing a new treatment option for people living with this chronic disease.”
The CHMP positive opinion will now be reviewed by the European Commission and a decision is expected before year end 2021. This positive opinion follows the previous approval of filgotinib for the treatment of patients with moderate to severe active rheumatoid arthritis. The use of filgotinib for UC is investigational and is not approved anywhere globally.
About Ulcerative Colitis
Ulcerative colitis (UC) is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2 million people (2) are affected by IBD, which includes UC and Crohn’s Disease (CD). UC is a chronic inflammatory condition of the gastrointestinal (GI) tract. The disease course of UC is often a state of flare ups and ensuing periods of remission. In addition to the physical impact from flare ups, there is also a significant psychological impact associated with UC. It causes significant impairments on quality of life and a poor prognosis is often seen in patients with symptoms of moderate to severe UC at diagnosis.
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). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The individual Great Britain and Northern Ireland Summary of Product Characteristics can be found at www.medicines.org.uk/emc and www.emcmedicines.com/en-GB/northernireland, respectively. Applications have been submitted to the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.
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 will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe, Great-Britain and Japan, and a global Phase 3 program is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.
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.
(1) Feagan. B., et al: Filgotinib as induction and maintenance therapy for ulcerative colitis: the SELECTION trial. The Lancet https://doi.org/10.1016/S0140-6736(21)00666-8.
(2) Burisch J. et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis (2013) 7, 322-337