FDA today licensed a new biotechnology product to treat patients with moderate to severe Crohn's disease, a chronic, incurable inflammatory bowel disease that causes diarrhea, cramping and abdominal pain and in some cases open holes (fistulae) leading from the intestine to the skin.
The new product, a monoclonal antibody called infliximab, is the first approved treatment for Crohn's disease. It is a genetically engineered antibody against a protein, tumor necrosis factor alpha, that promotes inflammation in the body. This antibody is manufactured using cells containing human and mouse antibody genes.
"Although not a cure, in the short-term, infliximab can have a dramatic impact on the quality of life of patients with severe forms of Crohn's disease," said Acting FDA Commissioner Michael A. Friedman, M.D. "We look forward to more long-term studies of the product so that patients and their doctors can use it in the most effective way possible."