Merck Announces Remicade Receives Positive Opinion From CHMP In Europe for Treatment of Ulcerative Colitis in Pediatric Patients

Merck

today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the use of REMICADE® (infliximab) in the treatment of severely active ulcerative colitis 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 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 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.