FDA Grants Breakthrough Therapy Designation for Certolizumab Pegol in Antiphospholipid Syndrome Pregnancies

The FDA granted Breakthrough Therapy Designation to certolizumab pegol (Cimzia) for preventing adverse pregnancy outcomes in high-risk women with antiphospholipid syndrome (APS). This designation expedites the development and review of therapies for serious conditions lacking approved treatments. APS is a rare autoimmune disorder causing severe pregnancy complications, and this move could lead to the first specific FDA-approved therapy for this indication.