Certolizumab pegol receives FDA BTD for adverse pregnancy outcomes in APS

On September 9, 2026, the FDA granted Breakthrough Therapy Designation (BTD) to certolizumab pegol (Cimzia; UCB) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have antiphospholipid syndrome (APS) and are positive for lupus anticoagulant and considered at risk due to prior obstetric and thrombotic events, UCB announced.

APS is a rare autoimmune disorder associated with increased risk of blood clots and serious pregnancy complications, including recurrent first-trimester pregnancy loss, preeclampsia, placental insufficiency, fetal growth restriction, preterm birth, and stillbirth. Despite this significant burden, patients are typically managed with low-dose aspirin and heparin, and there are currently no FDA-approved therapies for the prevention of adverse pregnancy outcomes in patients with APS.^1,2

BTD is granted to medicines intended to treat a serious or life-threatening condition when preliminary clinical evidence indicates the therapy may demonstrate substantial improvement over available treatments on one or more clinically significant endpoints, and is designed to facilitate development and expedite FDA review. The designation does not constitute marketing approval and does not establish the safety or efficacy of the therapy for the designated use.

What evidence supported the designation?

The designation is supported by preliminary clinical evidence from the IMPACT (IMProve Pregnancy in APS with Certolizumab Therapy; NCT03152058) study, an investigator-sponsored trial evaluating certolizumab pegol in pregnant women with APS at high risk of adverse pregnancy outcomes because of lupus anticoagulant positivity and prior obstetric or thrombotic manifestations of the disease.^1,3

Patients received certolizumab pegol added to standard treatment with low molecular weight heparin and low-dose aspirin from gestational weeks 8 through 28. The primary composite outcome was fetal death at 10 or more weeks of gestation, preeclampsia with severe features, or placental insufficiency requiring delivery before 34 weeks. Among the 45 patients in the primary efficacy population, 9 (20%; 95% CI, 9.6%–34.6%) met the primary adverse pregnancy outcome, and “significantly lower than rates in historical controls,” according to the study authors.⁴

Median gestational age at delivery was 36.5 weeks, neonatal survival to hospital discharge was 93%, and no serious infections or new lupus flares were reported.

“For women living with APS, pregnancy can be an especially challenging and uncertain experience,” said Jane E. Salmon, MD, Collette Kean Research Chair at the Hospital for Special Surgery and co-lead investigator of the IMPACT study.¹

“Despite current management approaches, many patients remain at risk of serious complications, including preeclampsia, intrauterine growth restriction, premature birth, and fetal death, highlighting the need for additional treatment options for this underserved population,” Salmon added. “Today’s designation represents an encouraging step forward in efforts to improve outcomes for women of childbearing age and their families.”

What is certolizumab pegol’s regulatory context for this indication?

The BTD builds on a prior FDA Orphan Drug Designation granted to certolizumab pegol for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with APS. Orphan Drug Designation is granted for therapies targeting rare diseases or conditions affecting fewer than 200,000 people in the United States and may provide development incentives and certain regulatory and commercial benefits, but does not constitute marketing approval.

Certolizumab pegol is not currently approved in pregnant women with APS, and its safety and efficacy have not been established for this use. The drug holds multiple existing FDA-approved indications across immune-mediated conditions including: Crohn’s disease, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and plaque psoriasis.

Certolizumab pegol is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of its excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

References:

1. UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA®(certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS). UCB. News release. Published September 9, 2026. Accessed September 9, 2026. https://prnmedia.prnewswire.com/news-releases/ucb-receives-us-fda-breakthrough-therapy-designation-for-cimziacertolizumab-pegol-in-pregnant-women-with-antiphospholipid-syndrome-aps
2. Antiphospholipid Syndrome. APS Foundation of America. Accessed September 9, 2026. https://apsfa.org/aps/
3. IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy. ClinicalTrials.gov. Updated April 1, 2026. Accessed September 9, 2026. https://clinicaltrials.gov/study/NCT03152058
4. Branch DW, Kim MY, Guerra MM, et al. Certolizumab pegol to prevent adverse pregnancy outcomes in patients with antiphospholipid syndrome and lupus anticoagulant (Impact): results of a prospective, single-arm, open-label, phase 2 trial. Annals of the Rheumatic Diseases. 2025;84(6):1011-1022. doi:10.1016/j.ard.2025.02.012