FDA Approves Remicade to Treat Ulcerative Colitis in Children Older than 6 Years

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.

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 arthritis (joint pain associated with psoriasis), and plaque psoriasis in adults.

The safety and efficacy of Remicade was supported by a multi-center, randomized, open-label study in 60 children ages 6 years to 17 years with moderately to severely active UC. All had failed to respond to or tolerate conventional treatment.

Remicade carries a Boxed Warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi or bacteria. There have been cases of unusual cancers reported in adolescent and young adult patients using TNF-blocking agents, including a rare and fatal type of cancer called Hepatosplenic T-cell Lymphoma.

Children should have all of their vaccines brought up to date before starting treatment with Remicade and should not receive live vaccines while taking Remicade. The most common side effects of Remicade are worsening of UC, upper respiratory infections, infusion-related reactions, and headache.

Remicade is manufactured by Janssen Biotech Inc. in Malvern, Pa.

For more information:

Information on Tumor Necrosis Factor (TNF) Blockers1
Approved Drugs: Questions and Answers2

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Posted: September 2011

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