FDA Approves New Biologic Drug to Treat Crohn’s Disease

The U.S. Food and Drug Administration (FDA) announced this week the approval of Cimzia (certolizumab pegol) for the treatment of moderate to severe Crohn’s disease in patients who have not responded to conventional therapies.

Cimzia, which is manufactured by UCB Inc. of Smyrna, Ga., is a pegylated anti-tumor necrosis factor drug. Patients receive an injection every two weeks for the first three doses and then injections every four weeks. The most common side effects include headache, upper respiratory infections and abdominal pain.

Because Cimzia affects the immune system, patients taking the drug are at increased risk for serious infections, including tuberculosis and other opportunistic infections. Patients taking Cimzia should be educated so they can recognize signs of infection and instructed to contact their health care providers should these signs develop. They may also be at increased risk of lymphomas and other malignancies.

“Crohn’s is a debilitating disease that disrupts the quality of life for its sufferers,” Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

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FDA Approves Cimzia to Treat Crohn’s Disease

A new drug has been approved to help sufferers of Crohn’s disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. This product was approved with a Medication Guide.

Crohn’s disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn’s can cause 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.

“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.

Cimzia is manufactured by UCB, Inc., Smyrna, GA.

For more information on Crohn’s disease, visit:
Crohn’s Disease–National Institute of Diabetes and Digestive and Kidney Diseases

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