New York, NY, October 1, 2005 - In September 2005, the Federal Drug Administration formally approved Remicade, also known as infliximab, for the treatment of ulcerative colitis in those who have not responded well to other medications. Ulcerative colitis is one of the diseases collectively known as inflammatory bowel disease that affects over one million Americans. The symptoms of ulcerative colitis include rectal bleeding, diarrhea, abdominal cramping, as well as extraintestinal complications including joint pain, eye inflammation and skin lesions.

Remicade is the first of a long line of a long line of “biologics,” a bioengineered antibody which is devised to act on a specific pathway or protein in the body. Remicade is an antibody engineered to block a particular cytokine (TNF-Alpha) which is central to the inflammatory response in the body.

According to clinical trials presented to the FDA, ulcerative colitis patients in the study experienced fewer flare-ups and had a higher rate of remission and healing of the bowel lining. Patients taking Remicade can experience serious infections, including tuberculosis and pneumonia. In addition, some patients can experience an infusion reaction to the drug and it can lose its effectiveness over time.

Previously, the drug had been approved only for the use in Crohn’s disease. Remicade is manufactured and marketed by Centocor, a division of Johnson & Johnson.

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