FDA has approved Janssen Biotech’s REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. This marks the 16th approval of REMICADER in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC. It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease. An estimated 150,000 children under age 17 are living with symptoms of IBD.
The approval is supported by evidence from adequate and well-controlled studies of REMICADE in adults with ulcerative colitis plus additional data from a pivotal phase III randomized, multicenter, open-label trial evaluating the efficacy and safety of REMICADER in the treatment of pediatric patients with moderately to severely active UC. Results from the pediatric UC study showed that treatment with REMICADER 5 mg/kg induced clinical response in 73% of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.