Home » UCB to Appeal European Negative Opinion on Cimzia
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.
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