UCB Pharma SA (BRUSSELS, Belgium) announced that it has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has rejected a marketing authorization in the EU for Cimzia® (certolizumab pegol) for reducing signs and symptoms and maintaining clinical response in patients with severe, active Crohn's disease who had not responded or who were intolerant to a full course of therapy with a corticosteroid or an immunosuppressant.

The market authorization application was based on the pivotal PRECiSE studies involving >1500 patients with moderate-to-severe Crohn's disease. The effectiveness of adding Cimzia to existing treatment was compared with placebo in two main studies. The first study looked at the reduction of symptoms during induction treatment in 660 patients who had not previously received Cimzia. The main measure of effectiveness was the proportion of patients whose symptoms had improved or disappeared after 6 and 26 weeks. The second study looked at the maintenance of the medicine's effects in 428 patients who had responded to an initial 6-week course of the drug. The main measure of effectiveness was the proportion of the patients who were still responding to treatment after 26 weeks. EMEA review began on May 24, 2006, with an active review time of 202 days.

According to CHMP, there was insufficient evidence to show a benefit of Cimzia. In the study of induction treatment, the drug showed only marginal effectiveness, which was too low to be relevant for patients. In addition, according to CHMP, the study of maintenance treatment did not last long enough to give meaningful information on the medicine's long-term effects. The committee was also concerned over the drug's safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving Cimzia. Therefore, CHMP was of the opinion that the benefits did not outweigh the risks and refused marketing authorization.

UCB plans to appeal and request that CHMP reexamine the submission. UCB may request a reexamination within 15 days of receipt of notification of this negative opinion. Should UCB file an appeal, a decision by the CHMP is expected during the first half of 2008.

UCB filed a Biologics License Application (BLA) with the US FDA for Cimzia in the treatment of Crohn's disease on February 28, 2006; Cimzia was approved in Switzerland for the treatment of Crohn's in September 2007. Preparation for a regulatory submission for the drug in the treatment of rheumatoid arthritis in the US is ongoing. Cimzia is the only PEGylated anti-TNFα therapeutic and has a high affinity for human TNFα, selectively neutralizing the pathophysiological effects.