Posted by Michael Wonder on 10 Jan 2018
Cimzia (certolizumab pegol) label change marks important advance for European women of childbearing age with chronic rheumatic disease
8 January 2018 - Data submitted to regulatory authorities included first-of-their-kind clinical studies demonstrating minimal transfer of Cimzia through the placenta and breast milk from mother to infant.
UCB today announced that the EMA approved a label change for Cimzia (certolizumab pegol), making it the first anti-TNF treatment option that could be considered for women with chronic rheumatic disease, during both pregnancy and breast-feeding.
The approval of the Cimzia label change in the EU is based on data from the post marketing CRIB and CRADLE studies as well as our pregnancy outcomes data. The studies included women with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and Crohn’s Disease (CD). In the EU, Cimzia is not indicated in CD.
