ROCKVILLE, Md., April 23 -- The FDA has approved certolizumab pegol (Cimzia) for adults with refractory moderate-to-severe Crohn's disease.
Though the drug reduces the symptoms of Crohn's, it is a tumor necrosis factor blocker that carries the risk of serious side effects including lymphomas and infection, according to the FDA. There was no increased risk of malignancy in initial studies.
"This drug … carries risks that will require patients to be closely monitored by their physicians or other healthcare professionals," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research.
Patients treated with certolizumab pegol will receive an injection every two weeks for the first three injections. Once benefit has been established, certolizumab pegol should be given once every four weeks, said the FDA.
The most common side effects are headache, upper respiratory infections, abdominal pain, injection site reactions, and nausea.
Post-marketing studies will be necessary to obtain long-term safety data, the FDA said.
The drug is manufactured by UCB Inc., in Smyrna, Ga.