- 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.
LONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new biomarker exploratory analyses from the Phase 2 DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren's disease (SjD)a showing that participants with elevated autoantibody and immunoglobulin G (IgG) levelsb, who are often those who experience more substantial disease burden, showed greater clinical response rates.1 These data will be presented in an oral session at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
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