JYSELECA®▼ (filgotinib) recommended by NICE for use in patients with Ulcerative Colitis (UC)

• UC is the most common form of inflammatory bowel disease, affecting 1 in every 420 people in the UK
• Patients are typically diagnosed in their 20s and 30s and live with the burden of UC for the rest of their lives

London, UK, 1^st June 2022 – Galapagos Biotech LTD announces that the National Institute of Health and Clinical Excellence (NICE) has recommended the use of JYSELECA^® (filgotinib) for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) when other treatments have not been successful. From today, filgotinib will be available for eligible patients across England, Wales and Northern Ireland on the NHS. Caused by chronic inflammation, UC impacts many aspects of a person’s life through many symptoms including frequent and irregular bowel movements, increased anxiety, and depression, as well as an increased risk of colon cancer.[i]

“Today’s recommendation from NICE regarding use of filgotinib in ulcerative colitis is excellent news for patients and healthcare professionals looking after people living with ulcerative colitis. This medicine has been shown to provide rapid symptom improvement, helping to ensure that not only are the debilitating symptoms such as diarrhoea and abdominal pain well-managed, but also, encouragingly, has the potential to aid holistic care with improvement in quality of life, in line with our aspirations for optimal care for our patients. As a once-daily tablet, the medicine provides an option for people to manage their condition in their own home, which could be convenient for some patients.” said Professor Jimmy K. Limdi, Consultant Gastroenterologist at the Northern Care Alliance NHS Foundation Trust and the University of Manchester.

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]

“Ulcerative Colitis is a chronic condition that can cause debilitating symptoms. It affects many parts of the body, from digestion and joints to energy levels and mental health. Around 1 in 5 people with Colitis are diagnosed before the age of 30, so will need lifelong treatment to manage their condition. For some people living with Colitis, existing treatments may not work, so we welcome the arrival of new treatment options to help people keep well” said Ruth Wakeman, Director of Services, Advocacy and Evidence at Crohn’s & Colitis UK.

“Over the last 23 years Galapagos has developed from a pioneering target discovery company to a fully integrated biotech that is committed to providing long-term solutions for people suffering with inflammatory conditions. We are proud with today’s recommendation from NICE and will continue our mission to deepen our understanding and research in the area.” said Emma Chaffin, VP & Country Head, Galapagos UK and Ireland.

NICE’s decision to recommend filgotinib will enable eligible patients currently living in England, Wales and Northern Ireland to access the treatment immediately. The news follows a decision from the Scottish Medicine Consortium’s (SMC), which also recommend filgotinib for use in moderate to severely active UC earlier this month.

[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