Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.UCB has been informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use has adopted a negative opinion on the market authorization application in the EU for Cimzia, for the treatment of patients with Crohn's disease.
Subscribe to our email newsletter
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.”