· Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with Sjögren's disease while preserving immune function
· New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group
· Previously reported data from the Phase 2 study showed nipocalimab reduced Sjögren's disease activity and severity, with potential to address systemic manifestations and the most burdensome patient-reported symptoms including dryness, fatigue and pain
· Nipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA for the treatment of adults with moderate-to-severe Sjögren's disease.