FDA approves certolizumab label update for pregnancy, breastfeeding

The manufacturer of certolizumab pegol, UCB, announced March 22 that the Food and Drug Administration approved a label update to the biologic that includes pharmacokinetic data showing negligible to low transfer of the biologic through the placenta and minimal mother-to-infant transfer from breast milk.

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The approval allows women with any of the chronic inflammatory diseases for which certolizumab pegol (Cimzia) is indicated, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and Crohn’s disease, to take the biologic throughout their reproductive health journey. It’s based on data from the postmarketing CRIB and CRADLE pharmacokinetic studies. In the United States, approximately 17% of patients with these chronic inflammatory diseases are women aged 18-45 years.

In the CRIB study, certolizumab levels were below the lower limit of quantification (defined as 0.032 mcg/mL) in 13 out of 15 infant blood samples at birth and in all samples at weeks 4 and 8. No anticertolizumab antibodies were detected in mothers, umbilical cords, or infants.