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www.fdanews.com/articles/114729-fda-ucb-agree-no-more-cimzia-studies

FDA, UCB Agree: No More Cimzia Studies

February 18, 2009
UCB won’t have to conduct more studies to support its BLA for the Cimzia treatment for rheumatoid arthritis. The Belgian drugmaker says the FDA is requiring further analysis of existing data and a new safety update. The company received a complete response letter for its BLA for Cimzia (certolizumab pegol) for rheumatoid arthritis last month. It anticipates submitting its full response in the second quarter.
Washington Drug Letter