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MHRA license Jyseleca for treatment of ulcerative colitis

pharmafile | January 19, 2022 | News story | Research and Development  

Galapagos NV, the Belgian parent company of Galapagos Biotech Ltd, have announced that Jyseleca® (filgotinib 200mg tablets) has been granted a marketing authorisation by the MHRA as a new treatment of ulcerative colitis (UC).

The submission was supported by data from the Phase IIb/III SELECTION programme, published in the Lancet. The decision from the MHRA closely follows authorisation from the European Commission (EC) for use in the same patient population.

“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,” shared Dr Fraser Cummings, Consultant Gastroenterologist at Southampton General Hospital UK, and Principal Investigator for the SELECTION study in the UK. “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.”

The MHRA has licensed an additional indication for Jyseleca, an oral once-daily, JAK1 preferential inhibitor. This approval is for use of Jyseleca 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.

UC is a life-long condition characterized by inflammation of the mucosal lining of the colon and rectum. Current estimates suggest that more than 146,0002 people are currently living with UC in the UK alone. The prevalence of inflammatory bowel disease, which includes UC, is rising in the UK, with peak diagnosis in late adolescence or early adulthood. UC causes inflammation and sores in the digestive tract, and symptoms include diarrhoea, tummy pain, and the need to frequently empty bowels. Some patients also experience painful and swollen joints, fatigue, areas of painful and swollen skin, and mouth ulcers.

Ana Ovey

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