HORSHAM, Pa.―Janssen Biotech, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (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 REMICADE® 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’s 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.1
“Ulcerative colitis can be a devastating disease and previously there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy,” said Dr. Jeffrey Hyams, Head of the Division of Digestive Diseases and Nutrition at Connecticut Children’s Medical Center and Professor of Pediatrics at University of Connecticut School of Medicine, and lead study investigator. “The approval of infliximab represents an important treatment milestone in the care of children stricken with this inflammatory bowel disease.”
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 3 randomized, multicenter, open-label trial evaluating the efficacy and safety of REMICADE® in the treatment of pediatric patients with moderately to severely active UC. Results from the pediatric UC study presented in May 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.
“Today’s approval of REMICADE® is significant for children and their families who are affected by this devastating disease and are seeking an effective treatment option,” said Rob Bazemore, president, Janssen Biotech, Inc. “We are proud of our heritage in the continued pursuit of expanding treatment options for patients living with immune-mediated inflammatory diseases like IBD.”
REMICADE® was designated orphan drug status by the FDA on Nov. 12, 2003, and the supplemental Biologics License Applications (sBLA) for pediatric UC received priority review following its submission to the FDA in December 2010. The FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) recommended the approval of REMICADE® in pediatric patients with UC.
On Sept. 1, 2011, Janssen Inc. announced Health Canada approved REMICADE® for the treatment of pediatric patients (age six to 17 years) with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.