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

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Basel, Switzerland – 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 life5,6. 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 undiagnosed8,9. 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 disease10,11. 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.

 

About Novartis 

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

 

Novartis in Immunology

At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across Rheumatology, Dermatology and Allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. From small molecules to biologics and CAR-T cell therapy, our pioneering science is focused on where we can have the greatest impact on patient outcomes. And by elevating the patient voice and building on a common purpose across the healthcare ecosystem, we are not just addressing the needs of people with autoimmune diseases – we’re reimagining medicine, together.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

 

References

  1. Grader-Beck T, et al. Ianalumab demonstrates significant reduction in disease activity in patients with Sjögren’s Disease: Efficacy and safety results from two global Phase 3, randomized, placebo-controlled double-blind studies (NEPTUNUS-1 and NEPTUNUS-2). Presented at the American College of Rheumatology (ACR) Congress; October 24-29, 2025; Chicago, Illinois.
  2. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Selected Immune Disorders and Disability. Sjögren’s Disease/Syndrome. [Last accessed: December 2025] https://www.ncbi.nlm.nih.gov/books/NBK584486/
  3. Dorner T, et al. Safety and efficacy of ianalumab in patients with Sjögren’s disease: 52-week results from a randomized, placebo-controlled, Phase 2b dose-ranging study. Arthritis Rheumatol. 2025; 77(5):560–570.
  4. U.S. Food and Drug Administration. Breakthrough therapy. [Last Accessed: December 2025] https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
  5. Negrini S, et al. Sjögren’s syndrome: a systemic autoimmune disease. Clin Exp Med. 2022; 22(1):9–25
  6. Mariette X, Criswell LA. Primary Sjögren’s symptoms. N Engl J Med. 2018;378:931–939
  7. Gairy K, et al. Burden of illness among subgroups of patients with primary Sjögren’s syndrome and systemic involvement. Rheumatology. 2021; 60(4):1871–1881
  8. Conrad N, et al. Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. Lancet. 2023;401(10391):1878–1890
  9. Narváez J, et al. Prevalence of Sjögren’s syndrome in the general adult population in Spain: estimating the proportion of undiagnosed cases. Sci Rep. 2020;10(1):10627
  10. ClinicalTrials.gov NCT05350072 [Last accessed: December 2025]
  11. ClinicalTrials.gov NCT0539214 [Last accessed: December 2025]

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