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FDA Approves AbbVie's Humira For Pediatric Ulcerative Colitis

AbbVie (ABBV) said that the U.S. Food and Drug Administration approved Humira or adalimumab for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.

The approval was based on results from the pivotal Phase 3 ENVISION I study, which showed that the higher dosage of Humira induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission at Week 52.

HUMIRA is now approved in the U.S. for use in 11 indications, including 5 approvals in pediatric populations.

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.

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