The U.S Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of moderate to serve Crohn's disease in adults who have not responded to other therapies.
"Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research. "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."
Cimzia is to be given, by injection, every two weeks for the first 3 injections and once the medication's benefit has been established patients are to receive the injection every four weeks. The most common side effects to the drug are headache, abdominal pain, injection site reactions, upper respiratory infections and nausea.
Cimzia is a blocker of tumor necrosis factor (TNF) and can cause lymphomas. UBC Inc. will be conducting the required post-market studies and trials to obtain long-term safety data.
For a complete explanation of Crohn's please read: What is Crohn's Disease.
[Source: FDA]
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