CHMP Upholds Negative Opinion for UCB’s Cimzia

UCB has announced that the European Medicines Agency Committee for Medicinal Products for Human Use has rejected the appeal, following CHMP refusal of the marketing authorization application for Cimzia in the treatment of patients with Crohn’s disease, a chronic and debilitating inflammatory disease.

This decision comes following an appeal the company filed after a previous negative opinion was adopted by the CHMP in November 2007 and only applies to UCB’s filing for Cimzia in Crohn’s disease in the EU.

Olav Hellebo, senior vice president UCB & president inflammation operations, said: “The CHMP’s negative opinion is disappointing for UCB. Nevertheless, we are pleased that specific safety and quality concerns raised by the committee in November, were resolved through the appeal process.”