MHRA approves Jyseleca®▼ as new treatment for ulcerative colitis

Jan 20, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for JYSELECA®▼ (Filgotinib), as a new treatment for ulcerative colitis (UC) in 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.

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.

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.”

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.”

Read more news from the Bowel Interest Group.