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Share this article Share this article With this approval, HUMIRA, an anti-TNF monoclonal antibody, offers pediatric patients from five years of age with moderately to severely active ulcerative colitis (UC) the first subcutaneous anti-TNF treatment option 1 Approval based on results from the pivotal Phase 3 ENVISION I study, the largest clinical trial in pediatric ulcerative colitis to date, showing HUMIRA provided significant rates of response and remission both at week 8 and 52 1,2 MONTREAL, April 22, 2021 /CNW/ - AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved HUMIRA ® (adalimumab) for inducing and maintaining clinical remission in pediatric patients five years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine or who are intolerant to such therapies.

Anne griffithsJulie lepsetzTracey ramsaySusan cowanAccess economics ptyAbbvie corporationInflammatory bowel disease centreHealth canadaVice presidentGeneral managerAllergan aestheticsEconomic costsAcute severe colitisChildren with ulcerative colitisInflammatory bowel diseasePediatric subjects with moderate