Afshan Arjumand Ianalumab received Food and Drug Administration (FDA) Breakthrough Therapy designation for Sjögren’s disease, the 2nd most common rheumatic autoimmune disorder. Ianalumab is a fully human mAb with unique dual mechanism of action that depletes β-cells and prevents activation and survival of β-cells via BAFF-R blockade. Novartis will submit for regulatory approval of ianalumab globally beginning in early 2026. If approved, it would be the 1st targeted therapy available to treat Sjögren’s disease. “The Breakthrough Therapy designation demonstrates our belief that Ianalumab has the promise to significantly improve the standard of care for those living with Sjögren’s disease, which...