Brussels, Belgium, September 9, 2026
UCB announced that the U.S. 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 with antiphospholipid syndrome (APS) who test positive for lupus anticoagulant (LA). The designation represents an important regulatory milestone for the biopharmaceutical company as it advances CIMZIA into a potential new use for a rare and serious autoimmune disorder associated with significant pregnancy complications. The FDA designation is supported by preliminary clinical evidence from the investigator-initiated IMPACT Phase 2 study, which evaluated certolizumab pegol in pregnant women with APS who were considered at high risk of adverse pregnancy outcomes.
FDA Breakthrough Therapy Designation Targets Unmet Need
The FDA grants Breakthrough Therapy Designation to medicines intended to treat serious or life-threatening conditions when preliminary clinical evidence indicates that the therapy may provide a substantial improvement over available treatment options on clinically significant endpoints. The designation is intended to facilitate drug development through more intensive FDA guidance and organizational support and can help expedite the regulatory review process. However, Breakthrough Therapy Designation is not FDA marketing approval and does not establish the safety or efficacy of CIMZIA for APS in pregnancy. Antiphospholipid syndrome is a rare autoimmune condition characterized by antiphospholipid antibodies that can increase the risk of blood clots and serious pregnancy complications. Pregnant women with APS can experience recurrent pregnancy loss, pre-eclampsia, placental insufficiency, fetal growth restriction, premature birth and stillbirth. Current management commonly involves low-dose aspirin and heparin, but there are currently no FDA-approved therapies specifically for preventing adverse pregnancy outcomes in patients with APS. This unmet medical need provides the clinical and regulatory context for the FDA’s designation.
IMPACT Study Supports CIMZIA Development
The regulatory decision was supported by findings from the IMPACT study, or IMProve Pregnancy in APS with Certolizumab Therapy. The investigator-sponsored study evaluated certolizumab pegol in pregnant women with APS who had a high risk of adverse pregnancy outcomes because of lupus anticoagulant positivity and previous obstetric or thrombotic manifestations. Published Phase 2 findings demonstrated the potential of CIMZIA to help prevent adverse pregnancy outcomes in this high-risk population. The study also contributes to the scientific rationale for targeting tumor necrosis factor (TNF)-mediated inflammation in APS-associated pregnancy complications. While APS is strongly associated with abnormal blood clotting, inflammatory mechanisms may also contribute to placenta-mediated complications. Certolizumab pegol is a TNF blocker, providing a potential mechanism for addressing inflammatory pathways involved in these complications. The FDA’s decision follows the company’s earlier receipt of Orphan Drug Designation for CIMZIA for the same potential use in APS.
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CIMZIA Advances Toward Potential New Indication
CIMZIA is already an established TNF-blocking biologic with approved indications in the United States for several immune-mediated conditions, including rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and moderate-to-severe plaque psoriasis. However, CIMZIA is not currently approved for pregnant women with APS, and UCB states that safety and efficacy for this potential use have not yet been established. The new FDA designation could help UCB accelerate development and regulatory discussions around this potential indication. For women with APS who face pregnancy-related complications despite existing management approaches, the development program represents an effort to address a significant unmet medical need. Further clinical and regulatory work will be required before CIMZIA could potentially receive an expanded indication for the prevention of adverse pregnancy outcomes associated with APS. UCB said the designation reinforces its focus on immune-mediated and rare diseases, particularly areas where treatment options remain limited. As development continues, additional clinical evidence will be important to determine whether the benefits observed in the IMPACT study can support a future regulatory application for this specific use of certolizumab pegol.
Source: UCB press release
