Cimzia Approved to Treat Crohn's Disease - Another New Crohn's Drug

The US Food and Drug Administration has approved a new drug for sufferers of Crohn's disease. Certolizumab pegol (Cimzia) received approval for use in 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 is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, MD, Director, Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA, Rockville, Maryland. "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 healthcare professionals."Patients treated with certolizumab will receive an injection every 2 weeks for the first 3 injections. Once benefit has been established, certolizumab should be given once every 4 weeks.The most common side effects of certolizumab are headache, upper respiratory infections, abdominal pain, injection-site reactions, and nausea.Patients taking certolizumab are at increased risk for serious adverse effects, including serious infections that can lead to hospitalisation or death. Because certolizumab affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections. Certolizumab is a tumour necrosis factor inhibitor and may cause lymphomas and other malignancies. Although an increased risk of tumours was not noted in studies of certolizumab, the modest size and relatively short duration of the controlled studies prevent any firm conclusion. Postmarketing studies and clinical trials will be required to obtain long-term safety data.Patients taking certolizumab should be educated about how to identify an infection and should be instructed to contact their healthcare professional at the first sign of infection. In cases of serious infections, the drug should be discontinued immediately.SOURCE: US Food and Drug Administration