UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA[®] (certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS)

Brussels (Belgium), 9 September 2026 – 07:00 (CEST) – 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 (APOs) in at-risk pregnant adult women withwho have antiphospholipid syndrome (APS) in addition to standard anti-coagulant therapy.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 It recognizes the potential of CIMZIA® to address a significant unmet medical need.^3,4 in an area where thereThere are currently no FDA-approved therapies for the prevention of adverse pregnancy outcomes in patients with APS.⁵ 

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.⁶

APS is a rare autoimmune disorder associated with increased risk of blood clots and serious pregnancy complications, ^3,7,8 including recurrent pregnancy loss in the first trimester, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth and stillbirth.⁷ 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.⁸

"For women living with APS, pregnancy can be an especially challenging and uncertain experience," said Prof. 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.⁹ 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

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

Global Communications
Adriaan Snauwaert 
T: +32.497.70.23.46 
Email: adriaan.snauwaert@ucb.com

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

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.^3,4

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)⁶
Breakthrough Therapy Designation (BTD) is a U.S. Food and Drug Administration (FDA) programme 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 organisational commitment to support efficient development and review, and is not a label indication approval.

About Orphan Drug Designation¹⁰
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 EU/EEA 
In the EU, CIMZIA^® (certolizumab pegol) in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs), including MTX, has been inadequate. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Certolizumab pegol in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Certolizumab pegol has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX.

Certolizumab pegol, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

Certolizumab pegol is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

• Ankylosing spondylitis (AS) – adults with severe active AS who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs (NSAIDs). 
• Axial spondyloarthritis (axSpA) without radiographic evidence of AS – adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have had an inadequate response to, or are intolerant to, NSAIDs.

Certolizumab pegol is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 

CIMZIA^® (certolizumab pegol) EU/EEA Important Safety Information
Cimzia^® (certolizumab pegol) was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. In the placebo-controlled studies, patients receiving certolizumab pegol had an approximately 4 times greater duration of exposure compared with the placebo group. This difference in exposure is primarily due to patients on placebo being more likely to withdraw early. In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo. 

The commonly reported adverse reactions (≥1/100 to <1/10) in clinical trials with certolizumab pegol and post-marketing cases were viral infections (includes herpes  zoster, papillomavirus, influenza), bacterial infections (including abscess), rash, headache  (including migraine), asthenia, leukopenia (including lymphopenia, neutropenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension,  pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. 

Certolizumab pegol was initially studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period. Certolizumab pegol was subsequently studied in 317 patients with non-radiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006). 

Certolizumab pegol was also studied in patients with axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a clinical study for up to 96 weeks, which included a 48-week open-label run-in phase (N=736) followed by a 48-week placebo-controlled phase (N=313) for patients in sustained remission (C-OPTIMISE). Certolizumab pegol was also studied in a 96-week open-label study in 89 axSpA patients with a history of documented anterior uveitis flares. In all 4 studies, the safety profile for these patients was consistent with the safety profile in Rheumatoid arthritis and previous experience with certolizumab pegol.

Certolizumab pegol was studied in 409 patients with psoriatic arthritis (PsA) in the PsA001 clinical study for up to 4 years which included a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 168-week open-label treatment period. The safety profile for PsA patients treated with certolizumab pegol was consistent with the safety profile in RA and previous experience with certolizumab pegol. 

Certolizumab pegol was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 3 years. In the Phase III program, the initial and maintenance periods were followed by a 96-week open-label treatment period. The long-term safety profile of certolizumab pegol 400 mg every 2 weeks and certolizumab pegol 200 mg every 2 weeks was generally similar and consistent with previous experience with certolizumab pegol.

Serious adverse reactions, defined as an adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect, include sepsis, opportunistic infections, tuberculosis (including miliary, disseminated and extrapulmonary), herpes zoster, lymphoma, leukemia, solid organ tumors, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking certolizumab pegol due to adverse events vs. 2.7% for placebo.

Certolizumab pegol is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections, and moderate to severe heart failure (NYHA classes III/IV).

Serious infections including sepsis, tuberculosis and opportunistic infections (e.g., histoplasmosis, nocardia, candidiasis) have been reported in patients receiving certolizumab pegol. Some of these events have been fatal. Before initiation of therapy with certolizumab pegol, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, certolizumab pegol therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with certolizumab pegol. 

Reactivation of hepatitis B virus has occurred in patients receiving a TNF-antagonist including certolizumab pegol who are chronic carriers of the virus (i.e., surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with certolizumab pegol. Carriers of HBV who require treatment with certolizumab pegol should be closely monitored and in the case of HBV reactivation certolizumab pegol should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.  

TNF antagonists including certolizumab pegol may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease including multiple sclerosis; of formation of antinuclear antibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, certolizumab pegol should be discontinued and appropriate therapy instituted.

With the current knowledge, a possible risk for the development of lymphomas, leukemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with certolizumab pegol.

Adverse reactions of the hematologic system, including medically significant cytopenia, have been reported with certolizumab pegol. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on certolizumab pegol. Consider discontinuation of certolizumab pegol therapy in patients with confirmed significant hematological abnormalities.

Severe infections and neutropenia were reported in clinical trials with concurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28 modulator) and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone. Because of the nature of the adverse events seen with the combination of another TNF-antagonist with either abatacept or anakinra therapy, similar toxicities may also result from the combination of anakinra or abatacept and other TNF-antagonists. Therefore, the use of certolizumab pegol in combination with anakinra or abatacept is not recommended.  

There is limited safety experience with surgical procedures in patients treated with certolizumab pegol. The 14-day half-life of certolizumab pegol should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on certolizumab pegol should be closely monitored for infections, and appropriate actions should be taken. Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. 

Please consult the Summary of Product Characteristics in relation to other side effects, full safety and prescribing information.
European SmPC date of revision: September 2026.

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

CIMZIA^® (certolizumab pegol) U.S. 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.

HEMATOLOGICAL 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.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 approximately 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
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References

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