UCB to appeal negative CHMP decision on Cimzia

UCB has announced that it is to appeal the recent decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency to issue a negative opinion relating to the marketing authorisation in the European Union for Cimzia (certolizumab pegol) as a treatment for patients suffering from Crohn’s disease.

The company reports that it will use the standard appeals process to ask for a re-examination of its submission by the committee, with a decision on this appeal expected to be made at some point in the first half of next year.

Cimzia is the sole pegylated anti-tumour necrosis factor (TNF) and has a high affinity for human TNF-alpha, selectively neutralising its pathophysiological effects.

Melanie Lee, executive vice president of research and development at UCB, said: “UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of Cimzia.”

She added that the company will continue to cooperate with the committee in order to deal with its concerns and to facilitate the approval of the CHMP to enable this treatment option to become available to Crohn’s disease patients.

In June 2007, UCB presented positive clinical trial data to the European League Against Rheumatism in Barcelona concerning the use of Cimzia as treatment for rheumatoid arthritis.