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Diseases

Novartis Announces Positive Top-Line Results for Ianalumab in Phase III Trials for Sjögren's Disease

Strategic Insights

— 2 min read

Sjögren's disease is a chronic, disabling autoimmune disease affecting approximately 0.25% of the population, with an estimated 50% of patients undiagnosed. Novartis has announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren's disease. Both trials met the primary endpoint of demonstrating statistically significant improvements in disease activity.

Key Takeaways:

  • Novartis's Phase III trials, NEPTUNUS-1 and NEPTUNUS-2, demonstrated statistically significant reductions in disease activity for Sjögren's disease patients treated with ianalumab.
  • Ianalumab, a dual-action therapy targeting B-cell depletion and BAFF-R inhibition, has the potential to become the first targeted treatment approved for patients with Sjögren's disease.
  • The NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren's syndrome disease activity index (ESSDAI) compared to placebo.
  • Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease.
  • Novartis plans to present the NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical meeting and submit ianalumab to health authorities globally.
  • Sjögren's disease is a systemic, chronic autoimmune disorder causing inflammation and tissue damage, impacting the entire body, primarily affecting exocrine glands.
  • Approximately 0.25% of the population is affected by Sjögren's disease, with an estimated 50% of patients undiagnosed.
  • The risk of lymphoma is increased in patients with Sjögren's disease.

Statistics:

  • 0.25% of the population is affected by Sjögren's disease (Source: Narváez et al, 2020)
  • Approximately 50% of patients with Sjögren's disease are undiagnosed (Source: Narváez et al, 2020)
  • 90% of patients with Sjögren's disease experience dry eyes and dry mouth (Source: Maleki Fischbach et al, 2024)
  • 30-40% of patients with Sjögren's disease will also show extraglandular organ involvement (Source: Kerry et al, 2021)
  • The NEPTUNUS-1 trial enrolled 275 patients and was conducted over 52 weeks (Source: Novartis, 2025)
  • The NEPTUNUS-2 trial enrolled 504 patients and was conducted over 52 weeks (Source: Novartis, 2025)
  • Ianalumab demonstrated a statistically significant reduction in disease activity measured by ESSDAI in both NEPTUNUS-1 and NEPTUNUS-2 trials (Source: Novartis, 2025)

Sources:

1. Novartis data on file

2. Bowman S et al, Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled, phase 2b dose-finding trial, Lancet 2022; 399:161-71

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 and Rheumatology 2025, 77(5):560-570

4. Negrini S et al, Sjögren's syndrome: a systemic autoimmune disease, Clin Exp Med . 2022; 22(1): 9--25

5. Mariette, Primary Sjögren's symptoms, New England Journal of Medicine , 2018, 378;10

6. Ianalumab, Department of Health and Human Services, Fast Track Designation, US Food and Drug Administration, 2025

7. ClinicalTrials.gov [Last accessed: August 2025]

8. ClinicalTrials.gov [Last accessed: August 2025]

9. ClinialTrials.gov [Last accessed: August 2025]

10. Maleki Fischbach M, et al, Manifestations and management of Sjögren's disease, Arthritis Res Ther. 2024;26(1):43

11. 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

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