Jyseleca approved in the European Union for the treatment of ulcerative colitis.

The European Commission approved an additional indication for Jyseleca, an oral, once-daily, JAK1 preferential inhibitor, for 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.

The Commission based its decision on data from the Phase 11b/111 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in the patient population now included in the label. The SELECTION trial was published in The Lancet.

Professor Laurent Peyrin-Biroulet, Professor of Gastroenterology and Head of the Inflammatory Bowel Disease (IBD) group at the Gastroenterology Department, University Hospital of Nancy, France, and Principal Investigator for the SELECTION study, said: “Despite available treatments for managing UC, there is still a need for new and innovative therapies like Jyseleca. UC is an incurable and disabling disease; in severe cases we aim to keep patients out of hospital and reduce the need for surgical procedures such as colectomies. Overall, our goals are to manage the symptoms that have a significant, negative impact on a person’s overall well-being, to be able to stop the use of steroids and to improve the daily life of patients. In the SELECTION study we observed filgotinib’s tablet form was easily administered, provided significantly greater corticosteroid-free clinical remission from symptoms compared to placebo and was well tolerated by patients.”