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.
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.
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.
Cimzia's most common side effects are headache, upper respiratory tract infections, abdominal pain, injection site reactions, and nausea, according to the FDA, which notes that Cimzia may also raise the risk of serious and potentially fatal infections and increased risk of lymphomas (a type of cancer) and other malignancies.
"As seen with the use of other anti-TNF-alpha agents, serious but infrequent infections and malignancies have been reported," UCB says in a news release.
The FDA notes that although an increased risk of tumors was not seen in studies of Cimzia, those studies were too small and too brief to make a firm conclusion about tumor risk, so postmarketing studies and clinical trials will be required to get long-term safety data.
The FDA says patients taking Cimzia should be taught 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, Cimzia should be discontinued immediately, the FDA says.