UCB plans to utilise the appeal process to request a Committee for Medicinal Products for Human Use (CHMP)re-examination of the submission. A decision is expected during the first half of 2008.
Melanie Lee, executive vice president research & development of UCB, said: “UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of Cimzia. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's disease.”