JYSELECA®▼ (FILGOTINIB) LICENSED FOR THE TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS PATIENTS IN GREAT BRITAIN

JYSELECA^®▼ (FILGOTINIB) LICENSED FOR THE TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS PATIENTS IN GREAT BRITAIN

London, UK; 19 January 2022; 09:00 GMT: Galapagos NV, the Belgian parent company of Galapagos Biotech Ltd, announced today that the  Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Jyseleca® (filgotinib 200mg tablets), as a new treatment for ulcerative colitis (UC) for Great Britain.

The MHRA has licensed an additional indication for Jyseleca, an oral once-daily, JAK1 preferential inhibitor, for use in 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 submission was supported by data from the Phase 2b/3 SELECTION program, published in the Lancet¹. The decision from the MHRA closely follows authorisation from the European Commission (EC) for use in the same patient population.

Emma Chaffin, Vice President and Country Head at Galapagos UK said, “This decision means that eligible adults with moderately to severely active UC, who still live with the debilitating symptoms of this condition in Great Britain will now be able to get access to Jyseleca. At Galapagos we are committed to bringing new and innovative medicines to healthcare professionals who are treating patients with UC and today we are one step closer to making this new treatment option available for thousands of patients living with this chronic disease.”

Dr Fraser Cummings, Consultant Gastroenterologist at Southampton General Hospital UK, and Principal Investigator for the SELECTION study in the UK said: “In the UK, 1 in every 420 people are estimated to have ulcerative colitis (UC),  a condition that can leave people feeling fatigued and depressed with symptoms that include faecal urgency, incontinence, bloody diarrhoea and pain. All of which can impact on many aspect of individuals’ lives as well as on their families, healthcare systems and society. Yet despite the prevalence of this disease, current treatment options  may not provide the symptom relief that patients hope for. Having another option to treat eligible patients for this debilitating disease is very welcome.”

UC is a life-long condition characterized by inflammation of the mucosal lining of the colon and rectum. Current estimates suggest that in the UK more than 146,000² people are currently living with UC. The prevalence of inflammatory bowel disease, which includes UC, is rising in the UK with peak diagnosis in late adolescence or early adulthood³.

Ruth Wakeman, Director of Services, Advocacy & Evidence, Crohn’s & Colitis UK, said: “Ulcerative Colitis can be an extremely debilitating condition, affecting many parts of the body, from digestion and joints to energy levels and mental health. It can affect people in very individual ways, so effective and appropriate treatment based on personalized care and shared decision making is really important. For some people with UC, existing treatments may not work, so additional treatment options are welcome.”

About filgotinib                                                              

Filgotinib is licensed and marketed as Jyseleca (200mg and 100mg tablets) in, Great Britain, the European Union 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 licensed and marketed as Jyseleca in Great Britain and in the European Union for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. An application has been submitted to the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active UC and is currently under review. The Great Britain Summary of Product Characteristics for filgotinib can be found at https://www.medicines.org.uk/emc/product/11810/smpc and the Northern Ireland Summary of Product Characteristics for filgotinib can be found at https://www.emcmedicines.com/en-gb/northernireland/medicine. 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. 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.

About Galapagos

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. Ulcerative colitis. NHS (2021). Available at: https://www.nhs.uk/conditions/ulcerative-colitis/#:~:text=It’s%20estimated%20around%201%20in,15%20to%2025%20years%20old [Accessed: October 2021]
3. Malodecky NA., et al: Increasing incidence and prevalence of inflammatory bowel disease with time, based on a systematic review. Gastroenterology 2012; 142:46-54

Contacts

Media:

Rhian Linney

Senior Communications Manager Therapeutic Areas

+44 (0) 7425 639465

Forward-looking statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development in UC, RA, Crohn’s Disease or other indications due to safety or efficacy concerns or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for other indications, such regulatory authorities requiring additional studies, the risk that Galapagos will not be able to continue to execute on its currently contemplated business plan and/or will need to revise its business plan, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the risk that Galapagos estimations regarding the commercial potential of filgotinib may be incorrect, the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the risk that the transition will not be completed on the currently contemplated timeline or at all, and the risk that the transition will not have the currently expected results for our business and results of operations, Galapagos’ estimations regarding the outroll in Europe, including Great Britain, may be incorrect and, the uncertainties relating to the impact of the COVID-19 pandemic on our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.