UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA®(certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS)

UCB received U.S. FDA Breakthrough Therapy Designation for CIMZIA (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome who are positive for lupus anticoagulant. The designation is supported by the investigator-sponsored IMPACT study, a Phase 2 single-arm open-label trial, and builds on the Orphan Drug Designation CIMZIA received for this indication on March 2, 2026. No FDA-approved therapies currently exist for preventing adverse pregnancy outcomes in APS patients, who are typically managed with low-dose aspirin and heparin, giving CIMZIA first-mover optionality in a rare-disease population.

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