FDA Approves Label Update for Cimzia Addressing Low Risk of Fetal Exposure

The FDA has approved a label update that includes pharmacokinetic data showing negligible to low transfer of Cimzia^® (certolizumab pegol) through placenta and minimal transfer to breast milk from mother to infant. The label update is relevant, since approximately 17% of patients in the US with RA, AS, PsA and CD are women aged 18-45, according to UCB.

According to the company, research in RA and CD patients has shown that the consequences of active disease during pregnancy can have serious implications for both mother and infant, including an increased risk of miscarriage, difficulties in the third trimester and birth, an increased risk of preterm delivery, and the infant being small for gestational age.

The approval of the CIMZIA label update is based on data from the post-marketing pharmacokinetic CRIB and CRADLE studies. The studies included women with RA, PsA, AS and CD.

Limited data from the ongoing pregnancy registry on use of CIMZIA in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.

“It is well recognized that women with chronic inflammatory disease face uncertainty during motherhood, given the lack of information on treatment during pregnancy and breastfeeding. Many women with chronic inflammatory disease discontinue their biologic treatment during pregnancy, often when they need disease control the most,” said CRADLE lead study author Megan E. B. Clowse, MD, MPH, Duke University Medical Center. “These data for CIMZIA provide important information to empower women and healthcare providers making decisions about treatment during pregnancy and breastfeeding.”

“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. During this significant time in their lives, we’re proud to offer support and important treatment information to women and their physicians as they plan for pregnancy and adequate disease management,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB. “UCB is executing on its Patient Value Strategy to connect the unmet needs of patients with innovative science. This new label update reaffirms UCB’s commitment to providing cutting edge research, developing medicines that treat serious, chronic diseases and supporting underserved patient populations with unmet needs, like women of childbearing age.”

UCB has been studying how biologic drugs impact women of childbearing age. Findings from two first-of-their-kind studies have strong implications for this patient population as they consider pregnancy. Based on results from the landmark CRIB study, there is negligible to low placental transfer evident from mother to child during pregnancy. Data from CRADLE, the prospective pharmacokinetic trial measuring the presence of an anti-TNF in breast milk, found minimal transfer of CIMZIA during lactation. UCB developed the CRADLE study with input from the FDA, including the agency’s Division of Pediatric and Maternal Health.