FDA Approves Cimzia Label Update Essential for Childbearing Women with Inflammatory Diseases

FDA Approves Cimzia Label Update Essential for Childbearing Women with Inflammatory Diseases
The U.S. Food and Drug Administration (FDA) recently approved UCB’s request for a label update for Cimzia (certolizumab pegol) indicating low transfer levels of the medication from mother to child through the placenta and breast milk. The move marks an important advance in providing key information on the care of women with Crohn's and other chronic inflammatory diseases throughout their reproductive years. "Recognition and public support for the unique family planning needs of women with chronic inflammatory disease is crucial for this underserved population. The label change for CIMZIA is important for women and their treating physicians to make informed decisions to manage their condition along their pregnancy journey," Emmanuel Caeymaex, head of immunology and executive vice president of UCB's immunology patient value unit, said in a press release. Among other indications, Cimzia helps to reduce symptoms of Crohn’s disease and maintain clinical response in adults with moderate-to-severe disease who have had an inadequate response to conventional therapy. Approval of the Cimzia label update is based on data from two studies: the Phase 1 CRIB study (NCT02019602) and the Phase 1 CRADLE study (NCT02154425), both of which are complete. CRIB was designed to assess the potential level of placental transfer of Cimzia from pregnant women to their infants. The study followed 16 women who were at least 30 weeks pregnant and already receiving Cimzia at approved doses. In 13 of 15 blood samples at birth, Cimzia levels were too low to measure. The same result was observed for all samples after the fourth and eighth weeks. One child had a minimal level of Cimzia, 0.09% of the mother’s plasma concentration, at birth, and in another case, the baby, deliv
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