HHS NEWS

U.S. Department of Health and Human Services

P98-23                         FOOD AND DRUG ADMINISTRATION 
FOR IMMEDIATE RELEASE          Print Media:         301-827-6242
August 24, 1998                
                               Consumer Inquiries:  800-532-4440

FIRST TREATMENT FOR CROHN'S DISEASE APPROVED

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."

Infliximab is indicated for the reduction of the symptoms of moderate to severe Crohn's disease in patients who have not responded well to traditional treatments, including corticosteroids and other immunosuppressants, and antibiotics. The improvement in patients who had taken infliximab was measured in terms of the number of liquid or soft stools, number and severity of abdominal cramps, and the overall sense of well-being. In a clinical trial, patients benefited most from the treatment within a two to four-week period following a single dose of infliximab. The percentage of patients who maintain benefits decreased over the next few months. Currently, data are limited and inconclusive on the product's long-term effectiveness.

In another clinical trial, the treatment reduced the number of draining fistulas that occur in some cases of Crohn's disease -- a benefit that lasted five months at most. There are no data on the retreatment of these fistulas.

The most common side effects were related to the intravenous infusion itself and included rash, low blood pressure, chills, and chest pain. These symptoms were generally temporary. Other common side effects included infections, some serious, that responded to antibiotic treatment. In addition, patients occasionally developed antibodies which could have been associated in rare cases with symptoms similar to ones seen in patients with systemic lupus erythematosus. These symptoms were also temporary.

Because short-term use of infliximab has benefited patients with a serious disease, the product has received accelerated approval. As part of that approval, the manufacturer has committed to studies in the near future to help answer questions about the long-term safety and efficacy of infliximab.

Infliximab is manufactured by Centocor, Inc. Of Malvern Pa., and will be marketed under the trade-name Remicade.

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