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REMICADE® Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis
Date:9/23/2011

HORSHAM, Pa., Sept. 23, 2011 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This marks the 16th approval of REMICADE® in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with symptoms of IBD.(1)

"Ulcerative colitis can be a devastating disease and previously there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy," said Dr. Jeffrey Hyams, Head of the Division of Digestive Diseases and Nutrition at Connecticut Children's Medical Center and Professor of Pediatrics at University of Connecticut School of Medicine, and lead study investigator.  "The approval of infliximab represents an important treatment milestone in the care of children stricken with this inflammatory bowel disease."

The approval is supported by evidence from adequate and well-controlled studies of REMICADE in adults with ulcerative colitis plus additional data from a pivotal Phase 3 randomized, multicenter, open-label trial evaluating the efficacy and safety of REMICADE® in the treatment of pediatric patients with moderately to severely active UC.  Results from the pediatric UC study presented in May showed that treatment with REMICADE&#
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SOURCE Janssen Biotech, Inc.
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