UCB says FDA grants Breakthrough Therapy designation for Cimzia in pregnant women with APS

• UCB won FDA Breakthrough Therapy Designation for Cimzia to prevent placenta-mediated adverse pregnancy outcomes in high-risk pregnant adults with APS.
• Use targets patients positive for lupus anticoagulant, on standard anticoagulants, with prior obstetric or thrombotic events.
• Designation backed by preliminary evidence from the investigator-initiated IMPACT study; Cimzia is not approved for APS in pregnancy.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. UCB SA published the original content used to generate this news brief on September 09, 2026, and is solely responsible for the information contained therein.