Novartis Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease: First Targeted BAFF-R Blocking B-Cell Depleter Demonstrates Statistically Significant Disease Activity Reduction; Regulatory Submissions Planned Q1 2026
NEPTUNUS-1 and NEPTUNUS-2 met primary endpoints with clinically meaningful improvements in ESSDAI and patient-reported outcomes across 779 globally enrolled patients; ianalumab positioned to become first approved targeted treatment for second most prevalent rheumatic autoimmune disease Novartis announced that the U.S. Food and
