New indication granted for Remicade

May 30, 2006

Children with active Crohn's disease will now have a new treatmentoption as the FDA has given the regulatory nod to infliximab(Remicade, Centocor) for the treatment of the disease. Themonoclonal antibody works to reduce the inflammation of the bowelassociated with Crohn's by blocking the action of tumor necrosisfactor-alpha and inducing remission of the condition.

Children with active Crohn's disease will now have a new treatment option as the FDA has given the regulatory nod to infliximab (Remicade, Centocor) for the treatment of the disease. The monoclonal antibody works to reduce the inflammation of the bowel associated with Crohn's by blocking the action of tumor necrosis factor-alpha and inducing remission of the condition. The approval is based on results of a study of 112 children, aged six to 17 years old, with moderately to severely active disease who did not respond well to conventional therapies. The FDA is working with Centocor to update the Warnings section of the Remicade label to alert clinicians to rare reports of an aggressive form of T-cell lymphoma that has occurred during therapy with the drug. The agency said it will continue to monitor postmarketing data for incidence of serious infections and malignancies during therapy. Remicade was previously approved for the treatment of Crohn's disease in adults, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and ulcerative colitis.

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