AbbVie's Humira Gets FDA Approval For Pediatric Ulcerative Colitis

by Vandana Singh, Benzinga Editor

February 25, 2021 7:12 AM | 1 min read | Make a Comment

The FDA has approved AbbVie Inc's (NYSE: ABBV) Humira (adalimumab) to treat moderately to severely active ulcerative colitis in pediatric patients five years and older.
Approved dosing for HUMIRA will be determined based on the child's weight.
The approval was based on results from Phase 3 ENVISION I study, which showed that the higher dosage of Humira induced clinical remission in 60% of patients at Week 8 and 45% of patients, who responded at Week 8, were in remission at Week 52.
Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence, weight loss, and fatigue.
Price Action: ABBV closed 2.3% higher at $108.69 on Wednesday.

Posted In: Biotech News Health Care FDA General ulcerative colitis

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