Nipocalimab Receives Breakthrough Therapy Status for Sjögren’s Disease Michele B. Kaufman, PharmD, BCGP | May 9, 2025Nipocalimab, an investigational monoclonal antibody that blocks FcRn and reduces levels of circulating immunoglobulin G (IgG) antibodies, has received the FDA’s breakthrough therapy designation for the treatment of Sjögren’s disease.