Remicade Approved for Expanded Use

Centocor, Inc. has received approval from the FDA for Remicade for reducing signs and symptoms and inducing clinical remission in pediatric patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy. This approval establishes Remicade as the first biologic therapy approved for the treatment of pediatric Crohn’s disease, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and, in some sufferers, delayed development and stunted growth. Earlier this year, the sBLA for Remicade for the treatment of pediatric CD was designated Priority Review by the FDA.

The approval was based on data from the Phase III 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 which demonstrated that nearly 90% of pediatric patients with moderately to severely active CD who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with Remicade. Additionally, the patients who responded to Remicade therapy were then randomized for maintenance therapy every eight weeks or every 12 weeks. In the eight-week maintenance treatment group, nearly two-thirds or 64% of the patients were in clinical response at one year and more than half were in clinical remission at the end of one year (56%).