FDA Grants Breakthrough Therapy Designation to Certolizumab Pegol for Preventing Adverse Pregnancy Outcomes in Antiphospholipid Syndrome

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to certolizumab pegol (Cimzia; UCB) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome (APS) who are positive for lupus anticoagulant and at risk due to prior obstetric and thrombotic events. This designation aims to expedite the development and review of therapies for serious or life-threatening conditions where preliminary clinical evidence suggests substantial improvement over existing treatments.