Novartis’ Ianalumab Granted FDA Breakthrough Therapy Designation for Sjögren’s Disease

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab for Sjögren’s disease. Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B cells and inhibits their activation and survival via BAFF-R blockade. 

“This breakthrough therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjögren’s disease, who currently don’t have effective treatment options for this debilitating disease,” said Angelika Jahreis, MD, PhD, global head of development, immunology, at Novartis. “We look forward to working with the agency through the regulatory review process with the hope of making ianalumab available to appropriate patients as quickly as possible.”

The designation is supported by positive data from multiple studies, including replicate Phase III trials NEPTUNUS-1 and NEPTUNUS-2, which delivered a clinically meaningful benefit, showing improvement in disease activity and reductions in patient burden. Ianalumab demonstrated a favorable safety profile with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies.

Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren’s disease.