HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis
AbbVie Inc. (ABBV)
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Source: PR Newswire
NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8.1,2"Ulcerative colitis can have a profound effect on children and for too long, treatment options for pediatric patients have been limited," said Brandee Pappalardo, vice president and head of U.S. immunology medical affairs, AbbVie. "This approval provides the first and only subcutaneous biologic for pediatric patients with ulcerative colitis that can be administered at home. This new indication for HUMIRA demonstrates AbbVie's commitment to patients with inflammatory bowel diseases and reinforces our goal of reducing the burden of this disease for patients."This approval
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