UCB Introduces Breakthrough CIMZIA Therapy for Treating Antiphospholipid Syndrome
UCB has introduced CIMZIA (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome (APS), a rare autoimmune disorder associated with blood clots and serious pregnancy complications.
CIMZIA is a tumour necrosis factor (TNF) inhibitor designed to reduce inflammation by blocking TNF activity. The therapy is administered by injection and is being investigated for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women with APS who are positive for lupus anticoagulant (LA) and have a history of obstetric or thrombotic events.
The designation is supported by preliminary clinical evidence from the IMPACT study involving women with APS considered at high risk of pregnancy complications. The study showed the potential of CIMZIA to prevent adverse pregnancy outcomes in women who were positive for LA and had previous obstetric or thrombotic complications. The findings also provide further evidence of a potential role for TNF-mediated inflammation in APS-related pregnancy complications.
APS is a rare autoimmune disorder that can cause blood clots and serious complications during pregnancy, including recurrent pregnancy loss, pre-eclampsia, placental insufficiency, restricted foetal growth, premature birth and stillbirth. Current treatment generally includes low-dose aspirin and heparin during pregnancy, but there are no FDA-approved therapies specifically for preventing adverse pregnancy outcomes in women with APS.
The FDA’s Breakthrough Therapy designation is intended to accelerate the development and review of medicines for serious conditions where preliminary clinical evidence indicates the potential for substantial improvement over available treatments. UCB is continuing to investigate CIMZIA for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women with APS.
CIMZIA is being evaluated for this use in pregnant women with APS who are considered at high risk because of lupus anticoagulant positivity and previous pregnancy or thrombotic complications. UCB also holds an FDA Orphan Drug designation for CIMZIA for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with APS. The therapy is not currently approved for this use, and its safety and efficacy have not yet been established.
