Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of 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. REMICADE was designated orphan drug status by the FDA on November 12, 2003 for the treatment of pediatric UC. REMICADE is currently approved for the treatment of adults with moderately to severely active UC who have not responded adequately to conventional therapy.
The sBLA is supported by data from a pivotal Phase 3, randomized, open-label trial that assessed the safety and efficacy of induction and maintenance REMICADE treatment in pediatric patients age six through seventeen who were diagnosed with moderately to severely active UC. Eligible patients had an inadequate response to treatment with conventional treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA) treatments.
"Data from the Phase 3 trial support the efficacy of REMICADE in inducing clinical response, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in pediatric patients with ulcerative colitis, an orphan disease that is in need of treatment options," said Jerome A. Boscia, M.D., Senior Vice President, Clinical R&D, Centocor Research & Development, Inc. "We are pleased to work with the FDA as we seek approval of REMICADE for the treatment of this very challenging disease."
Centocor Ortho Biotech Inc.