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AbbVie Receives Health Canada Approval of HUMIRA® (adalimumab) for the Treatment of Pediatric Patients with Moderately to Severely Active Ulcerative Colitis

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

AbbVie Receives Health Canada Approval of HUMIRA® for the Treatment of Pediatric Patients with Moderately to Severely Active Ulcerative Colitis

With this approval, HUMIRA, an anti-TNF monoclonal antibody, offers pediatric patients from five years of age with moderately to severely active ulcerative colitis 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 … 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

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

HUMIRA® Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

ABBVie today announced that the U.S. Food and Drug Administration approved HUMIRA ® for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8. 1,2 “Ulcerative colitis can have a profound effect on children and for too … ABBVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA ® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8. 1,2

United statesLeonard feinsteinMarla dubinskyBrandee pappalardoAccess economics ptyCenter at mount sinaiDrug administrationExchange commissionPartial mayo scoreFull mayo scorePediatric gastroenterologyMount sinai health systemMount sinaiMayo scoreMississippi riverFull prescribing information

HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis
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United statesLeonard feinsteinMarla dubinskyBrandee pappalardoAccess economics ptyCenter at mount sinaiDrug administrationExchange commissionPartial mayo scoreFull mayo scorePediatric gastroenterologyMount sinai health systemMount sinaiMayo scoreMississippi riverFull prescribing information