Delay likely for UCB's Cimzia in Crohn's

Belgian pharmaceutical group UCB has decided to initiate an additional short-term clinical evaluation of its drug Cimzia (certolizumab pegol) to confirm the induction of clinical response in moderate-to-severe active Crohn's disease. The company said it had worked closely with the US Food and Drug Administration to finalize the design of the study so as to provide additional clinical efficacy data.

Commenting, drug analysts at Lehman Brothers say it is not clear whether this additional trial will be required by the FDA as part of the New Drug Application filing for Cimzia in Crohn's (it is also being studied for psoriasis and rheumatoid arthritis), noting that, historically, the agency has often decided to wait for new data. This is especially the case if the new drug is of limited incremental benefit to patients, they point out. While this is one of the most important assets in UCB's pipeline, say the analysts, it is the fourth anti-tumor necrosis factor in its class and, if the agency does wait for the new study results, it will likely push the approval date back to early 2009.

UCB also explained that it expects to reply fully to the FDA's "complete response letter" of December last year by the end of April, but noted that this has raised no major issues or concerns regarding Cimzia's safety.