JYSELECA®▼ (filgotinib), recommended by the Health Service Executive (HSE) for people with Ulcerative Colitis (UC) in Ireland

• UC is the most common form of inflammatory bowel disease, affecting approximately 11,000 people in Ireland
• Patients are typically diagnosed in their 20s and 30s and will live with the burden of UC for the rest of their lives

London, UK, 2^nd May 2022 – Galapagos Biotech LTD today announces that further to approval from the Health Service Executive (HSE), eligible patients in Ireland will be able to access filgotinib, a once-daily tablet, a new medicine for the treatment of moderate to severe UC when other treatments have not been successful, via the health service. Caused by chronic inflammation, UC is a lifelong disability which impacts many aspects of a person’s life, causing frequent and irregular bowel movements, increased anxiety, and depression and a heightened risk of colon cancer.^[i]

“The approval of filgotinib by the HSE addresses the continued need for additional effective treatments for patients living with ulcerative colitis. By having the potential to provide relief from ongoing symptoms such as diarrhoea, urgency, bleeding and abdominal pain with a once-daily tablet, filgotinib provides patients with the option to manage their condition in the convenience of their own home. The potential to regain a normal quality of life offers a very welcome option for many living with this long-term disabling illness.” said Professor Glen Doherty, Consultant Gastroenterologist, St Vincent’s University Hospital

In a large phase 2b/3 study published in The Lancet, three times (200mg; 37.2% vs 11.2% p<0.0001) as many patients were in clinical remission with filgotinib compared to placebo at week 58. The use of filgotinib was shown to improve the quality of life and sustained clinical remission of patients in the study and reduce their exposure to steroids with their related side effects, compared to the patients on placebo.^[ii]

“Galapagos is committed to making sure that we fill areas of unmet need for patients, from research and discovery of potential new technologies, through to delivery to those in need. We are delighted with the decision from the Health Service Executive to approve filgotinib in ulcerative colitis and will continue our mission to improve the lives of people living with the burden of inflammatory conditions” said Emma Chaffin, VP & Country Head, Galapagos UK and Ireland.

The HSE’s decision to recommend filgotinib will enable eligible Irish patients access the treatment immediately. The news precedes decisions from the Scottish Medicine Consortium (SMC) and the National Institute of Health and Care Excellence (NICE), which are scheduled to issue recommendations regarding the use of filgotinib over the coming weeks.

[i] Clin Exp. Gastroenterol. Inflammatory bowel disease and anxiety: links, risks, and challenges faced

Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4376063/ Last Accessed: April 2022

[ii] The Lancet. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00666-8/fulltext Last Accessed: April 2022