FDA News

UCB To Launch Clinical Study For Cimzia To Meet FDA Demands

(March 22, 2007)--UCB has decided to initiate an additional short-term clinical study of CIMZIA (certolizumab pegol) to confirm the induction of clinical response in moderate to severe active Crohn's disease. UCB will work closely with the Food and Drug Administration (FDA) to finalise the design of the clinical study in order to provide additional clinical efficacy data. Furthermore, by the end of April 2007 UCB will also reply fully to the Complete Response Letter received on December 21, 2006.

In its Complete Response Letter, the FDA raised no major issues or concerns around the safety of CIMZIA or relating to Chemistry, Manufacturing and Controls (CMC) but did question the adequacy of one study design. UCB expects the results from this additional clinical study with CIMZIA in Crohn's disease in the second half of 2008.

The initial CIMZIATM development programme for the treatment of Crohn's disease met all primary endpoints with statistical significance. Therefore, whether this additional study, which was not part of the pivotal trials program initially agreed with the FDA, will be a pre-approval requirement or a post-approval commitment, is still the subject of the ongoing communications with the FDA.

UCB plans to file a Biologics License Application (BLA) with the FDA for CIMZIATM in the treatment of rheumatoid arthritis by year end 2007.

"We have complete confidence in CIMZIA's robust efficacy and competitive safety", commented Roch Doliveux, Chief Executive Officer, UCB, "CIMZIA will be, at launch, the first anti-TNF which is a PEGylated and Fc-free antibody fragment. We are looking forward to making this new treatment option available to patients who suffer from rheumatoid arthritis and Crohn's disease, and will continue our dialogue with the FDA in order to obtain approval for CIMZIA in the US as soon as possible".

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