Research

Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Jan 16, 2026

• 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
  
  

• Ianalumab has potential to become first targeted treatment for this autoimmune disease with significant unmet need

Basel, January 16, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease². 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 blockade³. 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.

“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, Global Head, Development, Immunology, 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.”

Building on the Fast Track designation that ianalumab was awarded in 2016, the FDA Breakthrough Therapy designation aims to expedite the development and review of therapies intended to treat serious conditions and address significant unmet needs⁴. Awarding of the Breakthrough Therapy designation is supported by positive data from multiple studies, including replicate phase III trials.

Sjögren’s disease is a serious, progressive, autoimmune condition that affects multiple organs causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma, which can carry a significant burden and impact on quality of life^5,6. Its heterogenous nature often causes it to go unrecognized or misdiagnosed⁷. Sjögren’s affects approximately 0.25% of the population, and it is estimated that 50% of people with Sjögren’s are undiagnosed^8,9. There are no approved targeted treatments available for Sjögren’s disease.

About NEPTUNUS-1 and NEPTUNUS-2  
The ianalumab Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, are global, multicenter, pivotal studies evaluating the efficacy and safety of ianalumab in patients with Sjögren’s disease^10,11. In both trials, ianalumab delivered a clinically meaningful benefit, showing improvement in disease activity and reductions in patient burden¹. Ianalumab demonstrated a favorable safety profile with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies¹.