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FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
Date:9/23/2011

SILVER SPRING, Md., Sept. 23, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.

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Remicade reduces signs and symptoms of UC and induces and maintains clinical remission in these patients.

UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum. Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss and fever. Between 50,000 and 100,000 children in the United States have IBD; of these, 40 percent have UC.

"With the approval of Remicade, children with moderately to severely  active  ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option," said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research. "However, there are serious risks associated with its use. Patients and their families should always discuss with their physician the risks and benefits of using a medication before deciding to start treatment."

Remicade belongs to a class of drugs called tumor necrosis factor (TNF) blockers. TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to autoimmune diseases. In addition to being approved for UC, Remicade is approved for the treatment of other autoimmune diseases such as Crohn's disease in adults and children older than 6 years, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthriti
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SOURCE U.S. Food and Drug Administration
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