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.”