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Jyseleca approved for treatment of adult patients with moderate to severe ulcerative colitis in United Kingdom.

Read time: 1 mins
Published:21st Jan 2022
The MHRA has licensed an additional indication for Jyseleca, an oral once-daily, JAK1 preferential inhibitor from Galapagos NV, for use in adult patients with moderately to severely active Ulcerative Colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

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

Dr Ian Beales, Consultant in Gastroenterology and General Medicine, Norfolk and Norwich University Hospital and Chief Investigator for the SELECTION study in the UK said: “The prevalence of UC in the UK is increasing. 1 in every 420 people are currently estimated to have the disease. Despite available treatments there is still a need for innovative new therapies to provide relief from the symptoms that can have debilitating physical consequences for patients. In the SELECTION study when compared to placebo, more patients on filgotinib 200mg demonstrated corticosteroid-free remission from clinical symptoms with improvements in measures of health-related quality of life and was well-tolerated by patients. We welcome having a new treatment option available to help us with managing this disease.”

Condition: Ulcerative Colitis
Type: drug

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