From the 50,000 to 100,000 children in the United States suffering from inflammatory bowel disease (IBD), 40% are affected by ulcerative colitis (UC). UC, a form of inflammatory bowel disease (IBD) affects the lining of the large intestine (colon) and rectum with symptoms including abdominal pain, diarrhea, rectal bleeding, weight loss and fever.

Remicade (infliximab), a drug for the treatment of moderate to severe active ulcerative colitis (UC) in children aged 6 years or more who had inadequate response to conventional therapy was today approved by the U.S. Food and Drug Administration (FDA). The drug, manufactured by Janssen Biotech Inc., reduces signs and symptoms of UC and induces and maintains clinical remission in these patients.

Remicade has been categorized in the drug class called tumor necrosis factor (TNF) blockers. TNF blockers suppress the immune system by disabling the activity of TNF, which is a substance in the body that can cause inflammation and lead to autoimmune diseases. Remicade has also been approved for treatments of other autoimmune diseases, including Crohn’s disease in adults and children aged 6 years or older, rheumatoid arthritis, ankylosing spondylitis (arthritis affecting joints in the spine and pelvis), psoriatic arthritis (joint pain linked to psoriasis), and plaque psoriasis in adults.

Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research said:

“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. 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’s safety and efficacy was assessed in a multi-center, randomized, open-label study conducted in 60 children aged between 6 to 17 years with moderately to severely active UC who all failed to respond to or tolerate conventional treatment.

The drug carries a Boxed Warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and viral, bacterial or fungal infections. In adolescent and young adult patients using TNF blockers, cases of unusual cancers have been reported, including a rare and fatal type of cancer called Hepatosplenic T-cell Lymphoma.

Children should have all vaccines updated before commencing treatment with Remicade and should not be administered to children receiving live vaccines. Remicade’s most common side effects include worsening of UC, upper respiratory infections, infusion-related reactions, and headache.

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

Written by Petra Rattue