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

ients had failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylates.  Patients received REMICADE® 5 mg/kg at weeks 0, 2, and 6.  The primary endpoint, clinical response at week 8, was defined as a decrease from baseline in the Mayo score of at least 30 percent and at least 3 points, with a decrease in rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0/1.  Patients who achieved clinical response at week 8 were randomized to receive REMICADE® 5 mg/kg every 8 weeks through week 46 or every 12 weeks through week 42.  Non-responders were discontinued from study agent.  

Safety data from the pediatric UC trial were consistent with current REMICADE® labeling.  No new safety concerns emerged in evaluating REMICADE® in the treatment of a pediatric UC population.

For more information regarding the safety profile for REMICADE®, please see "Important Safety Information" below.  

About Ulcerative Colitis

Ulcerative colitis (UC) is a chronic IBD of the colon.  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 debilitating symptoms of IBD.(1)  

About REMICADE®

REMICADE® was the first anti-TNF-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE® has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn's disease, psoriasis, and pediatric UC.  The safety and efficacy of REMICADE® have been well established in clinical trials over
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SOURCE Janssen Biotech, Inc.
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