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Crohn's Disease Health Center

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FDA OKs New Crohn's Disease Drug Cimzia

Cimzia Approved to Treat Crohn's in Adults Who Don't Respond to Other Treatments
WebMD Health News
Reviewed by Louise Chang, MD

April 23, 2008 -- The FDA has approved a new prescription drug called Cimzia to treat Crohn's disease in adults who haven't responded to other conventional therapies.

Cimzia, given by injection, targets an inflammatory chemical called tumor necrosis factor (TNF) alpha. Patients would get a shot of the drug once every two weeks at first, and then get a monthly injection if the first three shots are beneficial.

Cimzia "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," Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, says in an FDA news release.

UCB, the drug company that makes Cimzia, says that Cimzia will be available in the U.S. within 48 hours of the drug's approval on April 22.

WebMD first reported on Cimzia in July 2007, when The New England Journal of Medicine published results from the drug's clinical trials.

(What do you think about trying such a new medication? Talk with others on WebMD's Crohn's and Colitis: Support Group board.)

About Crohn's Disease

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, abdominal pain, and 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," Beitz says.

Cimzia's Approval

According to UCB, the FDA approved Cimzia based on clinical trials that included more than 1,500 Crohn's patients. The patients either got Cimzia or a placebo drug.

Among patients with moderate to severe Crohn's, those taking Cimzia were more likely than those taking the placebo to have their Crohn's symptoms ease for up to six months, UCB notes.

"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," Beitz says.

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