EMA CHMP issues positive opinion to MSD's REMICADE for treatment of pediatric UC

Published on January 21, 2012 at 3:31 AM · No Comments

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.

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