The European Commission has approved use of biologic drug Remicade (infliximab) for treatment of severe active Crohn's Disease in pediatric patients aged 6 to 17 years who have not responded to or are not tolerant of conventional therapies, it was announced June 7th.

Remicade thus becomes the only biologic therapy approved in the European Union for treatment of pediatric Crohn's Disease, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss.

"Crohn's disease significantly impacts the quality of life of children suffering from this condition," said Dr. Salvatore Cucchiara of the University of Naples. "Infliximab provides physicians with a new treatment option that addresses the unique aspects of this difficult-to-treat disease in the pediatric population."

In May 2006, the FDA approved Remicade for treatment of U.S. pediatric patients with moderately to severely active Crohn's Disease who have had an inadequate response to conventional therapy. Remicade was approved in the U.S. for adult Crohn's disease in 1998 and for adult ulcerative colitis in 2005.

Centocor discovered Remicade and has exclusive marketing rights to the product in the United States. Schering-Plough markets the biologic in most countries outside of the United States.