UCB has presented promising late-stage data which the Belgian company believes will support its until-now thwarted attempts to get the drug approved by US and European regulatory authorities for Crohn’s disease.

The firm has released six-week data from a 539-patient Phase IIIb trial called WELCOME, which demonstrated that Cimzia (certolizumab pegol), is effective in treating patients with Crohn's disease who are intolerant or no longer responding to infliximab. At week six of the 26-week trial, 61% of patients receiving subcutaneous injections of Cimzia 400mg at weeks 0, 2 and 4 had achieved the primary endpoint of a decrease in Crohn's disease, with 39% in remission.

Cimzia, the first and only PEGylated anti-tumour necrosis factor alpha drug, gained approval for Crohn's disease in Switzerland. However, the European Union’s Committee for Medicinal Products for Human Use (CHMP) in November adopted a negative opinion on UCB's bid to get Cimzia approved in that indication.

The Brussels-headquartered firm immediately appealed that move and is now expecting a fresh decision from the CHMP during the first half of this year. Also last year, the firm was asked by the US Food and Drug Administration for additional information on data submitted in its Biologics License Application for the Crohn's disease. The agency raised no major issues or concerns about the safety of Cimzia but did question the adequacy of one study design, and UCB submitted its response in April 2007.

If approved, Cimzia would compete with Abbott Laboratories’ Humira (adalimumab), which was approved by the FDA in January. UCB has also submitted a BLA for Cimzia to treat rheumatoid arthritis.