AbbVie’s Humira (adalimumab) Receives Health Canada’s Approval for Pediatric Patients with Active Ulcerative Colitis

April 23, 2021 Auto Bot AbbVie, approval, Health Canada, patients, Pediatric, receives, regulatory, Ulcerative Colitis 0

Shots:

  • The approval is based on P-III ENVISION I study that involves assessing the efficacy, safety, and PK of Humira (SC) in pediatric patients aged 4-17yrs. with mod. to sev. UC
  • The study met its co-1EPs of clinical remission @8wks, patients who responded @8wks, achieved clinical remission @52wks., no new safety signals were identified
  • Humira is the 1st SC anti-TNF therapeutic option for pediatric patients from 5yrs. of age with the mod. to sev. active UC who had an inadequate response to conventional therapy including corticosteroid and azathioprine or 6-mercaptopurine or who are intolerant to such therapies

Click here to­ read full press release/ article | Ref: Newswire Canada | Image: BioSpace

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