• Antiphospholipid syndrome (APS) is a serious autoimmune condition that mainly affects women of childbearing age (WoCBA) and can cause serious adverse pregnancy outcomes, with no therapies currently approved.
• The Breakthrough Therapy Designation (BTD) is supported by findings from the investigator-initiated IMPACT study, which demonstrated the potential of CIMZIA^® to address a significant unmet need for women with APS.
• The designation builds on the recent Orphan Drug Designation for CIMZIA^® in APS and reinforces UCB’s long-standing commitment to advancing innovation for people living with rare diseases, including sustained investment in research that supports women throughout their reproductive journey.

ATLANTA, Sept. 9, 2026 /PRNewswire/ — 08:00 (EST) – UCB, a global biopharmaceutical company, today 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 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.¹

The designation is supported by preliminary clinical evidence from the IMPACT study,² and recognizes the potential of CIMZIA to address a significant unmet medical need^3-4 in an area where there are currently no FDA-approved therapies for the prevention of adverse pregnancy outcomes in patients with APS.^2-6

A 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. The designation is designed to facilitate development and expedite the FDA review of promising new therapies.⁷

APS is a rare autoimmune disorder associated with increased risk of blood clots and serious pregnancy complications,^3,8-10 including recurrent pregnancy loss in the first trimester, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth, and stillbirth.⁸ Despite the significant burden of the condition, patients are typically managed with low-dose aspirin and heparin,⁴ highlighting a substantial unmet medical need.^3-4

“This designation is a testament to UCB’s commitment to advancing innovation in areas of significant unmet need, including our long-standing focus on supporting women of childbearing age,” said Donatello Crocetta, Chief Medical Officer and Global Head of Medical Affairs at UCB. “Building on our experience across immune-mediated conditions, we continue to explore new approaches for people living with rare diseases and other underserved conditions where treatment options remain limited.”

Results from the IMPACT study demonstrated the potential of CIMZIA to prevent adverse pregnancy outcomes in women with APS considered high risk due to LA positivity and prior obstetric or thrombotic manifestations of the disease. The findings add to growing evidence implicating tumor necrosis factor (TNF)-mediated inflammation in APS-related pregnancy complications.¹⁰

“For women living with APS, pregnancy can be an especially challenging and uncertain experience,” said Dr. Jane E. Salmon, Collette Kean Research Chair, Hospital for Special Surgery, and Co-Lead Investigator of the IMPACT study. “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. Today’s designation represents an encouraging step forward in efforts to improve outcomes for women of childbearing age and their families.”

The designation builds on the FDA’s recent Orphan Drug Designation for CIMZIA for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with APS.¹¹ CIMZIA is not currently approved in pregnant women with APS, and the safety and efficacy have not been established for this use.

Notes to editors

About antiphospholipid syndrome (APS)
Antiphospholipid syndrome (APS) is a rare and serious autoimmune condition that mainly affects women of childbearing age (WoCBA), characterized by the presence of antiphospholipid antibodies, which can cause repeated blood clots in arteries and veins.^2-3,5 The condition is associated with serious pregnancy complications, including recurrent pregnancy loss in the first trimester, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth, stillbirth, and a range of serious placenta-mediated adverse pregnancy outcomes.^3-4,9

Current standard-of-care treatment typically includes low-dose aspirin and heparin during pregnancy^4-5; however, no therapies are currently approved specifically for the prevention of adverse pregnancy outcomes in this patient population.^3-5

About the IMPACT Study
IMPACT (IMProve Pregnancy in APS with Certolizumab Therapy) was an investigator-sponsored study evaluating certolizumab pegol in pregnant women with APS at high risk of adverse pregnancy outcomes. Published results demonstrated the potential of certolizumab pegol to prevent adverse pregnancy outcomes in this high-risk population.²

About Breakthrough Therapy Designation (BTD)⁷
Breakthrough Therapy Designation (BTD) is an FDA program intended to expedite the development and review of  medicines for serious or life-threatening conditions. The designation is granted when preliminary clinical evidence indicates that a therapy may demonstrate substantial improvement over available treatment options on one or more clinically significant endpoints. BTD provides opportunities for more intensive FDA guidance and organizational commitment to support efficient development and review, and is not a label indication approval.

About Orphan Drug Designation¹²
Orphan Drug Designation is granted by the FDA to medicines intended for the treatment, prevention, or diagnosis of rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation is designed to encourage the development of therapies for rare diseases and may provide incentives to sponsors, including development support and certain regulatory and commercial benefits. The designation does not constitute marketing approval or determine a medicine’s safety or efficacy.

About CIMZIA^® (certolizumab pegol) in the U.S.

• CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:
  • Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
  • Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
  • Treatment of adult patients with active psoriatic arthritis (PsA)
  • Treatment of adults with active ankylosing spondylitis (AS)
  • Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation 
  • Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy

Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.

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

SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

• Do not start CIMZIA during an active infection, including localized infections.
• Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
• If an infection develops, monitor carefully and initiate appropriate therapy.

MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.

• Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
• In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
• In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
• Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
• Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
• Cases of acute and chronic leukemia were reported with TNF blocker use.

HEART FAILURE

• Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

HYPERSENSITIVITY REACTIONS

• Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex that may cause an allergic reaction in individuals sensitive to latex.

HEPATITIS B VIRUS REACTIVATION

• Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
• Test patients for HBV infection before initiating treatment with CIMZIA.
• Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
• Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

NEUROLOGIC REACTIONS

• TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

HEMATOLOGIC REACTIONS

• Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
• Consider stopping CIMZIA if significant hematologic abnormalities occur.

DRUG INTERACTIONS

• Do not use CIMZIA in combination with other biological DMARDs.

AUTOIMMUNITY

• Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

• Avoid use of live vaccines during or immediately prior to initiating CIMZIA. Update immunizations in agreement with current immunization guidelines prior to initiating CIMZIA therapy.

ADVERSE REACTIONS

• The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

Please see ucb-usa.com for full prescribing information.

About UCB 
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB).

Forward-looking statements
This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document.

Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward.

Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.

UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

For further information, contact UCB:

Investor Relations
Yvonne Naughton
T: +44.175.344.7521 
Email: Yvonne.Naughton@ucb.com 

Sahar Yazdian
T +32.2.559.91.37
Email sahar.yazdian@ucb.com

Corporate Communications  
Laurent Schots
T: +32.2.559.92.6
Email: Laurent.schots@ucb.com

U.S. Communications
Nicole Herga  
T: +773-960-5349
Email: nicole.herga@ucb.com

References

1. U.S. Food and Drug Administration. Breakthrough Therapy Designation letter for CIMZIA^® (certolizumab pegol) for the prevention of adverse pregnancy outcomes in patients with antiphospholipid syndrome (APS). Date issued: August 2026. On file with UCB.
2. Branch DW, 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. Ann Rheum Dis. 2025;84(7):1011-1022.
3. Branch DW, Lim MY. How I diagnose and treat antiphospholipid syndrome in pregnancy. Blood. 2024;143(9):757-768.
4. Lee EE, Jun JK, Lee EB. Management of Women with Antiphospholipid Antibodies or Antiphospholipid Syndrome during Pregnancy. J Korean Med Sci. 2021;36(4):e24.
5. U.S. Food and Drug Administration (FDA). Drugs@FDA Database. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Last accessed: September 2026.
6. Adams CG, Rudnicki J, Petersen BF, et al. The urgent need for randomized controlled trials in pregnant women with antiphospholipid antibodies—protecting women through research. Front. Lupus. 4:1747204.
7. U.S. Food and Drug Administration. Breakthrough Therapy. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy. Last accessed: September 2026.
8. Murvai VR, Galiș R, Panaitescu A, et al. Antiphospholipid syndrome in pregnancy: a comprehensive literature review. BMC Pregnancy Childbirth. 2025;25:230.
9. Alijotas-Reig J, Esteve-Valverde E, Ferrer-Oliveras Ret al; EUROAPS Study Group. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 1000 consecutive cases. Autoimmun Rev. 2019;18(4):406-414.
10. Berman J, Girardi G, Salmon JE. TNF-α Is a Critical Effector and a Target for Therapy in Antiphospholipid Antibody-Induced Pregnancy Loss. J Immunol. 2005;174(1):485-490.
11. U.S. Food and Drug Administration (FDA). Search Orphan Drug Designations and Approvals: certolizumab pegol for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with antiphospholipid syndrome. Date designated: March 2, 2026. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/. Last accessed: September 2026.
12. Science Insights. Orphan Drug Designation: What It Means and How It Works. Available at: https://scienceinsights.org/orphan-drug-designation-what-it-means-and-how-it-works/. Last accessed: September 2026.

 

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