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FDA Approves Remicade for Children with Crohn’s Disease

May 19, 2006 -- Rockville, MD -- The Food and Drug Administration today 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 tumor necrosis factor-alpha (TNF-á), that was initially approved in 1998 to treat Crohn's disease in adults.

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, noted that 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 diarrhea, 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," he said. "We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated."

The safety and effectiveness of Remicade in pediatric Crohn's disease were assessed in a randomized study in 112 children who were 6 to 17 years old with moderately to severely active Crohn's disease who had an inadequate response to conventional therapies. The proportion of these patients who achieved clinical response compared favorably with the proportion of adults in an earlier Remicade study in adult Crohn's disease, and the pediatric trial's results showed no new safety concerns not already expressed in the product's current label.

In general, the safety profile for Remicade in the pediatric trial was similar to the data that was presented at an FDA Arthritis Advisory Committee meeting in March 2003, and that dealt with the extent to which anti-TNF therapies may increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain patients.

These risks, which are described in a study in the May 17 issue of the Journal of the American Medical Association, are included in the current labels for all approved TNF-alpha blocking agents, including Remicade.

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.

Source: The Food and Drug Administration

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