The US FDA approved Remicade (infliximab) to treat children with active Crohn's disease, a chronic, inflammatory condition of the bowel that can be severely debilitating. Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumour necrosis factor-alpha (TNF-a), that was initially approved in 1998 to treat Crohn's disease in adults.

Dr Steven Galson, director of the FDA's centre for drug evaluation and research, said, "There have been no satisfactory treatments for children with Crohn's disease who have moderate to severe disease activity despite traditional or conventional therapies. Crohn's disease can cause diarrhoea, cramping, abdominal pain, gastrointestinal bleeding, and in some cases creates abnormal connections (fistulas) leading from the intestine to the skin."

"Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy. We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated," he added.

More recently, the FDA has received rare post-marketing reports of an aggressive and often fatal type of T-cell lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with the Crohn's disease. In most, but not all cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-mercaptopurine) in combination with Remicade. The FDA is working with the manufacturer to address this risk by updating the warnings sections of the Remicade label.

FDA continues to actively and carefully monitor the safety experience with Remicade and similar therapies in an effort to maximize their very real benefits yet limit, to the degree possible, the potential for very serious toxicities.