Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease
Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease
arcticnovartis
- Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1
- Distinction expedites development and review of treatments for serious conditions that may demonstrate improvement over standard of care
- Novartis plans to submit to health authorities globally starting in early 2026