FDA GRANTS PRIORITY REVIEW FOR REMICADE

Centocor has reported that the supplemental biologics license application (sBLA) for Remicade (infliximab) for the treatment of pediatric Crohn's disease has been accepted and designated for priority review by the 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.

The filing is based primarily on Phase III 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.