UCB to Appeal European Negative Opinion on Cimzia

The Committee for Medicinal Products for Human Use has adopted a negative opinion on the market authorization application in the European Union for UCB’s Cimzia, a treatment for Crohn’s disease.

The Belgian drugmaker plans to appeal the decision and request that the committee reexamine the submission, UCB said.  A decision is expected during the first half of 2008.

UCB filed a biologics license application with the FDA for Cimzia (certolizumab pegol)  in the treatment of Crohn’s disease Feb. 28, 2006. The drug was approved in Switzerland for this indication in September.