MSD (also known as Merck in the United States and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of REMICADE®
(infliximab) in the treatment of severely active ulcerative colitis (UC) in pediatric patients ages 6 to 17 years, who have had an
inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. REMICADE, a monoclonal antibody that specifically targets tumor necrosis factor (TNF)-alpha, was approved in the European Union (EU) in March 2006 for the treatment of moderately to severely active UC in adults. REMICADE has been used in the treatment of inflammatory bowel disease (IBD) for more than 12 years in the EU, having been first approved for severely active Crohn's disease in adults in 1999, and more recently, moderately to severely active pediatric Crohn's disease in 2007.
Upon receipt of the corresponding Commission Decision, REMICADE will be the first and only biologic therapy approved in the EU for the treatment of pediatric UC, a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.
"For parents of children who suffer from the sometimes devastating effects of ulcerative colitis, the positive opinion adopted by the CHMP is encouraging news and a significant step towards making REMICADE available to a younger patient population in Europe," said Rupert Vessey, MRCP, DPhil, Senior Vice President, Research Laboratories, Merck. "Building on our
long heritage in immunology, today's positive opinion further reinforces the efficacy of REMICADE in the treatment of inflammatory bowel disease and our commitment to expanding treatment options for patients in Europe."
The CHMP adopted their opinion based on a review of data from a Phase 3 multicenter, randomized, open-label, parallel-group clinical study that assessed the efficacy and safety of REMICADE in 60 pediatric patients ages 6 through 17 years diagnosed with moderately to severely active ulcerative colitis who had experienced an inadequate response to conventional therapies. Findings from the 54-week study showed the efficacy of REMICADE in this pediatric population.
A final decision from the European Commission is expected during the first quarter of 2012.