UCB’s Cimzia wins FDA Breakthrough therapy status for antiphospholipid syndrome

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to Cimzia (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have antiphospholipid syndrome (APS) and are positive for lupus anticoagulant (LA).

These patients were considered at risk due to prior obstetric and blood clotting (thrombotic) events, said Belgian drugmaker UCB (Euronext: UCB), which markets the drug that reported first-half 2026 of 954 million euros ($1,108 million.