UCB: FDA Grants Cimzia Accelerated Status in Antiphospholipid Syndrome

A regulatory status aimed at accelerating development

UCB announced on September 9, 2026 that the Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to Cimzia (certolizumab pegol) for the prevention of pregnancy complications of placental origin in adult pregnant women with antiphospholipid syndrome (APS) and positive for lupus anticoagulant, in addition to standard anticoagulant treatment. The designation is based on preliminary clinical data from the IMPACT study, conducted at investigators' initiative. It aims to facilitate development and accelerate FDA review of therapies for serious or potentially life-threatening conditions. According to UCB, there is currently no FDA-approved therapy for the prevention of pregnancy complications in patients with APS, who are generally managed with low-dose aspirin and heparin.

Extension of orphan drug designation

This designation follows the Orphan Drug Designation recently granted by the FDA to Cimzia for the prevention of pregnancy complications of placental origin in patients with APS. Published results from the IMPACT study involved patients considered at high risk due to their positivity for lupus anticoagulant and obstetric or thrombotic history, and add to data implicating TNF-mediated inflammation in pregnancy complications related to APS. The group specifies that Cimzia is not approved in pregnant women with APS and that its safety and efficacy have not been established for this use. The BTD does not constitute an approval of indication. Donatello Crocetta, Medical Director and Global Head of Medical Affairs at UCB, indicated that the group continues to explore new approaches for people with rare diseases and conditions with limited therapeutic options.