Certolizumab pegol receives FDA Breakthrough Therapy Designation 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 is supported by preliminary clinical evidence from the IMPACT study, as there are currently no FDA-approved therapies for this indication.