By Michael Dabaie

 

AbbVie Inc. said Health Canada approved Humira for inducing and maintaining clinical remission in pediatric patients five years of age and older with moderately to severely active ulcerative colitis.

The approval is for pediatric patients who have had an inadequate response to conventional therapy including corticosteroids and azathioprine or 6-mercaptopurine or who are intolerant to such therapies.

Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence as well as weight loss and fatigue.

The Health Canada approval is based on results from the ENVISION I Phase 3 study. The study showed that Humira met the co-primary objectives of clinical remission at week 8 and, among those who responded at week 8, clinical remission at one year.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

April 22, 2021 10:44 ET (14:44 GMT)

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