FDA grants Breakthrough Therapy Designation to UCB's CIMZIA (certolizumab pegol)
核心洞察
The FDA granted Breakthrough Therapy Designation to CIMZIA (certolizumab pegol) for preventing placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome (搜索) who test positive for lupus anticoagulant.
The designation is supported by preliminary clinical evidence from the investigator-initiated IMPACT study, a prospective, single-arm, open-label phase 2 trial in high-risk pregnant patients with APS.
No therapies are currently FDA-approved to prevent adverse pregnancy outcomes in APS, where standard management relies on low-dose aspirin and heparin, and CIMZIA is not approved for this use.
UCB (搜索) announced that the U.S. FDA has granted Breakthrough Therapy Designation to CIMZIA (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome (搜索) (APS) who are positive for lupus anticoagulant (LA) and considered at risk due to prior obstetric or thrombotic events. The designation follows a recent Orphan Drug Designation for the same indication, granted March 2, 2026, and is supported by preliminary clinical evidence from the investigator-initiated IMPACT study.
IMPACT (IMProve Pregnancy in APS with Certolizumab Therapy) was a prospective, single-arm, open-label phase 2 trial evaluating certolizumab pegol in pregnant women with APS at high risk of adverse pregnancy outcomes; published results in Annals of Rheumatic Diseases demonstrated the drug's potential in this population. The findings add to evidence implicating TNF-mediated inflammation in APS-related pregnancy complications. APS is a rare autoimmune disorder associated with recurrent first-trimester pregnancy loss, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth and stillbirth, and is typically managed with low-dose aspirin and heparin.
CIMZIA is a TNF blocker approved in the U.S. for Crohn's disease, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and plaque psoriasis. It is not currently approved in pregnant women with APS, and safety and efficacy have not been established for this use. Breakthrough Therapy Designation is intended to expedite development and review and does not constitute a label indication approval.
Source: UCB press release