Pharmaprojects R&D Pipeline News Feed
Cimzia approved in the US for moderate-to-severe Crohn's disease
28 Apr 2008
UCB has announced that the US FDA has approved Cimzia (certolizumab pegol), the first and only PEGylated anti-TNFa antibody for use in Crohn's disease (CD). Cimzia is administered subcutaneously every four weeks, making it a convenient treatment for people with moderate-to-severe CD. Cimzia's approval was based on data from clinical trials in over 1500 patients suffering from CD, which demonstrated that a greater proportion of CD patients achieved a sustained clinical response with Cimzia for up to six months, compared to placebo. It was also shown that the majority of patients who were in remission after initial dosing maintained remission with no dose escalation necessary.
"The clinical trials programme has shown Cimzia to be an effective subcutaneously-administered treatment, with a low rate of injection site reactions," said Dr Stephen Hanauer, Professor of Medicine and Clinical Pharmacology at the University of Chicago. "The approval of Cimzia provides a new option for people with CD to achieve relief from this debilitating condition with a convenient, stable administration once every four weeks."
CD is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal tract, most commonly at the end of the small intestine and beginning of the large intestine. If not treated effectively, it may result in the need for surgery. It is estimated that there are as many as half a million people who suffer from CD in the US alone.
