UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA®(certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS)
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 Designation 12
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.
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:
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.
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.
HEART FAILURE
HYPERSENSITIVITY REACTIONS
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
DRUG INTERACTIONS
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
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).
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References
SOURCE UCB