EU green light for a new treatment for ulcerative colitis (Cu). The European Commission has approved the marketing of Jyseleca * (filgotinib 200 milligrams), a preferential inhibitor of the Jak1 enzyme to be taken as tablets once daily, for adult patients with moderate to severe active Cu who have had an inadequate response. , either they did not react or they were intolerant to conventional therapy or a biologic drug. This was announced by the Belgian company Galapagos NV, explaining that the authorization was based on data from the Phase 2b / 3 Selection program, which evaluated filgotinib as an induction and maintenance treatment in the patient population now included in the product information. The results were published in ‘The Lancet’.
“We are very pleased that the European Commission has approved Jyseleca as a treatment for people with ulcerative colitis – says Onno van de Stolpe, CEO of Galapagos – This decision further supports the efficacy and safety profile of the drug, which has been studied in over 1,250 Cu patients. Our aim now is to make this treatment available as quickly as possible to doctors and ulcerative colitis patients across the European Union. ”
Stresses Laurent Peyrin-Biroulet, professor of gastroenterology and head of the Inflammatory Bowel Diseases Group at the Department of Gastroenterology of the University Hospital of Nancy, France, principal investigator of the Selection study: “Despite the treatments available for the management of ulcerative colitis, c “There is still a need for new and innovative therapies such as Jyseleca. Cu is an incurable and disabling disease; in severe cases we aim to avoid and reduce the need for surgical procedures such as colectomy. Overall our goals are to manage the symptoms that have a negative and significant impact on a person’s general well-being – adds the specialist – in an attempt to stop the use of steroids and improve the daily life of patients. In the Selection study we observed that filgotinib in tablets was easily administered, provided a clinical remission of symptoms without the use of cor ticosteroids and was well tolerated by patients compared to placebo “.
Ulcerative colitis is a life-long condition that commonly begins in late adolescence or early adulthood and is characterized by inflammation of the lining of the colon and rectum. As an increasingly widespread disease, Cu has a significant negative impact on the quality of life of more than 2 million people in Europe. Despite current treatments, many patients experience fecal urgency, incontinence, recurrent bloody diarrhea, the need to frequently empty the bowels, abdominal pain, sleep disturbances and fatigue. Patients with severe ulcerative colitis may be hospitalized and undergo surgery that has a high impact on their life. In addition to the physical symptoms, there is also a significant psychological impact associated with the pathology.
An impact that “cannot be underestimated – highlights Luisa Avedano, CEO of the European Federation of Associations for Crohn’s disease and ulcerative colitis (Efcca) – It is important that each individual speaks to their doctor to understand which approach can work best in the optimal management of their condition. Having new treatment choices available is therefore very important, and at EFCA we are pleased to see that new options have been made available. ” Jyseleca is a trademark of Galapagos NV and Gilead Sciences Inc. or its related companies.
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