UCB’s CIMZIA breakthrough designation targets the placenta, not the clot. Is that the key to high-risk APS pregnancy?
The FDA has granted Breakthrough Therapy Designation to UCB’s CIMZIA for high-risk pregnant women with antiphospholipid syndrome after Phase 2 evidence suggested that adding TNF inhibition to standard aspirin and heparin could reduce severe placenta-mediated complications. The programme challenges a long-standing assumption that preventing thrombosis alone is sufficient to manage obstetric APS.