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AbbVie's Humira Gets FDA Approval For Pediatric Ulcerative Colitis

  • 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.

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Posted-In: ulcerative colitisBiotech News Health Care FDA General

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