April 22, 2008— UCB announced today that the US Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegylated), the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha) antibody indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.
"The approval of Cimzia® in the US is a significant milestone for both UCB and our Cimzia® team, but especially for people suffering from Crohn's disease," said Roch Doliveux, Chief Executive Officer of UCB Group. "Cimzia® is a UCB biological innovation that will provide a monthly treatment option for patients suffering from Crohn's disease. Cimzia® will be available to doctors and Crohn's patients in the United States, which represents 70% of the world Crohn's anti-TNF market, within the next 48 hours."
The approval of Cimzia® was based on safety and efficacy data from clinical trials in more than 1 500 patients with Crohn's disease. Each pivotal study demonstrated that a statistically significant greater proportion of moderate to severe Crohn's disease patients achieved and sustained clinical response with Cimzia® for up to six months, compared to placebo. These data also showed that of the patients who were in remission after initial dosing, the majority maintained remission with no dose escalation.
Cimzia® is the first and only PEGylated anti-TNFa. Cimzia® is dosed subcutaneously every four weeks after initial dosing, making it a convenient option for people with moderate to severe Crohn's. Cimzia® has demonstrated a low incidence of injection site reactions and injection site pain in clinical trials. The most common reported adverse events in the pivotal studies were upper respiratory tract infection (cold, flu), urinary tract infection (bladder infection) and joint pain. As seen with the use of the other anti-TNFa agents, serious, but infrequent infections and malignancies have been reported.
"The clinical trials program has shown Cimzia® to be an effective subcutaneously-administered treatment, with a low rate of injection site reactions," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology at the University of Chicago. "The approval of Cimzia® provides a new option for people with Crohn's disease to achieve relief from this debilitating condition with a convenient, stable administration once every four weeks."