NHS Scotland first in the UK to approve JYSELECA®▼ (filgotinib) for a form of Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)

• Treatment approved for people with moderately to severely active Ulcerative Colitis which causes symptoms such as persistent abdominal pain and an increased risk of colon cancer.
• Scotland has the highest rates of IBD in the UK, with around 20,000 specifically affected by UC.
• Lifetime medical costs for managing IBD are on par with conditions such as diabetes and cancer - exceeding £70m annually in Scotland.

London, UK, 9^th May 2022 – Galapagos UK today welcomes the decision from the Scottish Medicines Consortium (SMC) to recommend JYSELECA^® (filgotinib), a once daily tablet, for use by NHS Scotland for the treatment of adults with moderately to severely active UC, when other treatments have been unsuccessful. From today, nearly 2,000 Scottish patients will be able to gain access to the medicine,^[i] making Scotland the first country within the UK to routinely offer the treatment through the health service.^[ii]

“Ulcerative colitis is a chronic disorder characterised by the inflammation of the colon leading to bleeding and urgency. Today’s recommendation by the SMC is great news for the Scottish population suffering from UC. The data suggests that filgotinib is an effective drug in controlling inflammation in patients with a moderate to severe case of the condition. The evidence for this treatment appears to be very positive – with good efficacy, improvements in quality of life with once daily dosing that could be convenient for patients. I am pleased to have another option for my patients.” said Dr. Daniel Gaya, Consultant and Gastroenterologist, Glasgow Royal Infirmary.

“Cure Crohn’s Colitis is the only IBD charity in the UK which is committed to investing 100% of funds raised in high quality patient centred research and we support ongoing research to continue to find new and effective treatments. Great strides have already been made in introducing new drugs which improve the quality of life of patients struggling day to day with ulcerative colitis and following today’s recommendation I am pleased to see additional treatment options available.” said Roy Provan, Chair of Cure Crohn’s Colitis.

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.^[iii]

“Galapagos is pleased that the SMC has issued a positive recommendation for the use of filgotinib amongst eligible Scottish patients. We are committed to supporting people affected by inflammatory conditions and hope that this approval will support many more people to live happier, healthier lives.” said Emma Chaffin, VP & Country Head, Galapagos UK & Ireland.

[i] BMJ Journals. Gut - IBD prevalence in Lothian, Scotland, derived by capture–recapture methodology https://gut.bmj.com/content/68/11/1953 Last Accessed: April 2022

[ii] SMC. Product Update SMC2467 Filgotinib 100mg and 200mg film-coated tablets (Jyseleca) Galapagos Biotech.

[iii] 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