Announcement • Sep 09

UCB Receives U.S. FDA Breakthrough Therapy Designation For CIMZIA (Certolizumab Pegol) In Pregnant Women With Antiphospholipid Syndrome

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 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. The designation is supported by preliminary clinical evidence from the IMPACT study, and recognizes the potential of CIMZIA to address a significant unmet medical need in an area where there are currently no FDA-approved therapies for the prevention of adverse pregnancy outcomes in patients with APS. 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. APS is a rare autoimmune disorder associated with increased risk of blood clots and serious pregnancy complications, including recurrent pregnancy loss in the first trimester, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth, and stillbirth. Despite the significant burden of the condition, patients are typically managed with low-dose aspirin and heparin, highlighting a substantial unmet medical need. 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. 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. CIMZIA is not currently approved in pregnant women with APS, and the safety and efficacy have not been established for this use. 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. 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. Current standard-of-care treatment typically includes low-dose aspirin and heparin during pregnancy; however, no therapies are currently approved specifically for the prevention of adverse pregnancy outcomes in this patient population. 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. 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. 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. 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. 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. 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. 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. 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.

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