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.
"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.