UCB reveals CRL for Cimzia

UCB S.A. (Euronext:UCB) revealed in its 1Q17 earnings report that FDA issued a complete response letter last month for Cimzia certolizumab pegol to treat polyarticular juvenile idiopathic arthritis. UCB said the letter concerns the reliability of pharmacokinetic data in its submission. The company said it is working with FDA and a third party bioanalytical laboratory to address the issue.

Cimzia is approved in the U.S. to treat psoriatic arthritis, rheumatoid arthritis, Crohn's disease and ankylosing spondylitis. It is a pegylated humanized antibody fragment against tumor necrosis factor (TNF) alpha...