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# Breakthrough Therapy Designation for UCB’s Cimzia
- URL: https://www.fdaweb.com/breakthrough-therapy-designation-for-ucbs-cimzia/
- Published: 2026-09-09T12:00:00.000Z
- Updated: 2026-09-13T19:20:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161748

FDA has granted breakthrough therapy designation to UCB’s Cimzia (certolizumab pegol), a tumor necrosis factor blocker, to prevent placenta-mediated adverse pregnancy outcomes in pregnant women with antiphospholipid syndrome (APS) who are positive for lupus anticoagulant (LA). A company [statement](https://www.ucb.com/newsroom/press-releases/article/ucb-receives-us-fda-breakthrough-therapy-designation-for-cimziar-certolizumab-pegol-in-pregnant-women-with-antiphospholipid-syndrome-aps?ref=fdaweb.com) says the designation builds on a recent FDA orphan drug designation for Cimzia in APS.

The statement says the breakthrough designation was based on results from the IMPACT study that demonstrated Cimzia’s potential 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.

UCB notes that Cimzia is not currently approved by FDA for pregnant women with APS, and its safety and efficacy have not been established for this use.