AbbVie announced that Health Canada approved RINVOQ® (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]), an oral, once-daily selective and reversible JAK inhibitor, for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional, and/or biologic therapy.
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that can lead to substantial burden and often disability among patients. Canada has one of the highest rates of inflammatory bowel disease in the world, the two main forms of which are Crohn's disease and ulcerative colitis. More than 300,000 Canadians are living with IBD, and the rate of diagnosis is increasing amongst certain demographics including seniors.
"Patients with ulcerative colitis live with unpredictable symptoms, including bowel urgency, uncontrollable diarrhea, abdominal pain and rectal bleeding, which can significantly affect their quality of life often paralyzing them during a flare. The impacts of UC are far-reaching, affecting patients beyond physical symptoms with significant impacts on mental health." explains Dr. Remo Panaccione, MD, Professor of Medicine and Director of the IBD unit, University of Calgary. "The approval of RINVOQ is exciting and welcome news, as it represents a new selective class of treatment and is a once-daily oral therapy approved in UC. RINVOQ has demonstrated it can rapidly improve symptoms within days to get patients back on track with their lives while also healing the damaged bowel, paving the road to a brighter future without flares."
"At the height of my symptoms, UC dictated my life. For about five years I struggled with pain and worry. Going out to work or anything else was near impossible. Always worrying about needing a nearby restroom or what to be careful of eating had been recurring thoughts that tormented me daily. When you do everything you can to feel better but see no real results, you feel ready to give up," explained Ryan L., of Brampton, Ontario. "Once I found a treatment that worked for me, I felt normal again, which seemed like a miracle. Being able to go out again without the added worry makes one appreciate what it means to be healthy. I'm glad this new medication will be available for Canadians living with UC.”
"In a recent patient survey, we asked people if the currently available medications were adequate to control their disease. Sadly, only 24% of those living with IBD thought that the available medications were adequate," says Gail Attara, President and Chief Executive Officer of the Gastrointestinal Society. "People living with ulcerative colitis need access to new treatment options to help manage the unrelenting bowel symptoms and to hope for mucosal healing. I am pleased to learn that Health Canada has now approved RINVOQ for the treatment of adults with moderately to severely active ulcerative colitis."
"With more than 30 ongoing or planned trials in IBD, we are relentless in our commitment to elevate the standard of care for patients. Our many years of research experience have given us invaluable insights into the challenges faced by people living with UC, and a deep understanding of the continued need for new treatment options," said Tracey Ramsay, Vice President and General Manager, AbbVie Canada. "We celebrate this approval as it will make a meaningful difference in the lives of Canadians with UC."
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