Galapagos NV announced today that the European Commission has granted marketing authorization for Jyseleca® (filgotinib 200mg tablets) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
The European Commission approved an additional indication for Jyseleca, an oral, once-daily, JAK1 preferential inhibitor, for 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 Commission based its decision on data from the Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in the patient population now included in the label. The SELECTION trial was published in The Lancet (1).
“We are very pleased that the European Commission has approved Jyseleca as a treatment for people with UC. This decision further supports the efficacy and safety profile of Jyseleca, which was studied in over 1,250 UC patients. Our focus now is on making this treatment available as rapidly as possible to physicians and UC patients across the European Union,” said Onno van de Stolpe, CEO of Galapagos.
Professor Laurent Peyrin-Biroulet, Professor of Gastroenterology and Head of the Inflammatory Bowel Disease (IBD) group at the Gastroenterology Department, University Hospital of Nancy, France, and Principal Investigator for the SELECTION study, said: “Despite available treatments for managing UC, there is still a need for new and innovative therapies like Jyseleca. UC is an incurable and disabling disease; in severe cases we aim to keep patients out of hospital and reduce the need for surgical procedures such as colectomies. Overall, our goals are to manage the symptoms that have a significant, negative impact on a person’s overall well-being, to be able to stop the use of steroids and to improve the daily life of patients. In the SELECTION study we observed filgotinib’s tablet form was easily administered, provided significantly greater corticosteroid-free clinical remission from symptoms compared to placebo and was well tolerated by patients.”
UC is a life-long condition commonly starting in late adolescence or early adulthood and characterized by inflammation of the mucosal lining of the colon and rectum. As an increasingly prevalent disease, UC has a significant negative impact on the quality of life of more than 2 million2 people across Europe. Despite current treatments, many patients experience faecal urgency, incontinence, recurring bloody diarrhea, the need to empty their bowels frequently, abdominal pain, poor sleep, and fatigue. Patients with severe UC can be hospitalized and require life changing surgery. In addition to the physical symptoms, there is also a significant psychological impact associated with UC.
Luisa Avendano, CEO at the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) said: “The impact that living with UC can have on a person’s life cannot be underestimated. It is important for each individual to speak to their doctor about what approach will work best to help them manage their condition. Having new approved treatment choices is therefore very important, and at EFCCA we are pleased to see new options being made available.”
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 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 interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. 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. Applications have been submitted to 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 UC and are currently under review. 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. 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.
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.