New Crohn’s Disease Treatment Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved a new medicine called Cimzia for the treatment of Chron’s disease. The drug is manufactured by UCB, Inc., and is known as a tumor necrosis factor (TNF) blocker. It is used to reduce the signs and symptoms of moderately to severely active Crohn’s disease in adult patients who have not been helped enough by usual treatments.

Crohn’s disease is a condition that causes inflammation of the gastrointestinal tract, and most commonly occurs at the lower end of the small intestine. Typical symptoms include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. The disease affects more than 1 million men and women worldwide. It has no cure and its cause is unknown.

"Crohn’s is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn’s, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

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