AbbVie Gets Canada Approval of Humira in Pediatric Patients Ulcerative Colitis
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
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 firstname.lastname@example.org
(END) Dow Jones Newswires
April 22, 2021 10:44 ET (14:44 GMT)
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