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UCB finds a way forward for Cimzia for RA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB will not have to conduct an additional study to support a rheumatoid arthritis indication for Cimzia (certolizumab); the firm recently met with FDA to clarify the requirements needed for the expanded approval. Further analysis of existing data and a new safety update are required. UCB Chief Medical Officer Iris Loew-Friedrich said to anticipate the submission of their full response in the second quarter of this year. The firm received a "complete response" letter in January requesting more safety data on the tumor necrosis factor inhibitor, which is already approved for Crohn's disease (1"The Pink Sheet" DAILY, Jan. 5, 2009)

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