FDA approves Remicade for Pediatric Ulcerative Colitis

The FDA has approved Remicade (infliximab), from Janssen Biotech, for the treatment of moderately to severely active Ulcerative Colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. The approval was supported by evidence from studies of Remicade in adults with Ulcerative Colitis plus additional data from a pivotal Phase III trial evaluating the efficacy and safety of Remicade in the treatment of pediatric patients. Results from the pediatric UC study presented in May 2011 showed that treatment with Remicade 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.