Infliximab
FDA grants priority review of infliximab for children with Crohn's disease
By Centocor, Inc.
Apr 5, 2006, 14:06

Centocor, Inc. announced today that the supplemental Biologics License Application (sBLA) for REMICADE (R) (infliximab) for the treatment of pediatric Crohn's disease has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn's disease in patients who have had an inadequate response to conventional therapies. Currently, there are no approved biologic therapies for the treatment of pediatric Crohn's disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn's disease may also experience delayed development and stunted growth. Orphan drug designation was granted by the FDA to REMICADE for the treatment of pediatric Crohn's disease on November 12, 2003. In addition, on August 30, 2004 a REMICADE Phase 3 clinical development program for pediatric Crohn's disease was designated Fast Track by the FDA.

The filing is based primarily on Phase 3 study results showing the unprecedented efficacy of REMICADE in the treatment of children with moderately to severely active Crohn's disease. In the REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE in Pediatric Subjects with Moderate to Severe Crohn's Disease) trial, nearly 90 percent (88.4 percent) of pediatric patients with moderately to severely active Crohn's disease who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with REMICADE. Nearly two-thirds (63.5 percent) of the patients who were randomized to treatment with REMICADE every 8 weeks were in clinical response at one year. Additionally, more than half of the patients treated with REMICADE every 8 weeks were in clinical remission at the end of one year.

"We are extremely pleased by the results of the REACH trial and by the FDA's decision to accept the application with a Priority Review," said Jerome A. Boscia, MD, Senior Vice President, Clinical Research and Development, Centocor, Inc. "REMICADE, if approved for the treatment of pediatric Crohn's disease, would represent a major advancement for children with this serious condition. We look forward to working closely with the FDA as it reviews these data for approval."

Priority Review is granted by the FDA to products that are considered to be a potential therapeutic advance over current therapies. Acceptance of the sBLA filing does not mean that a license has been issued for this indication nor does it represent any evaluation of the adequacy of the data submitted in the sBLA. REMICADE was FDA-approved in 1998 as the first biologic treatment for adults with moderate to severe Crohn's disease. In September 2005, REMICADE also became the first approved biologic treatment for moderate to severe ulcerative colitis (UC), making it the only biologic indicated for the treatment of both types of inflammatory bowel disease (IBD) in adults.

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