Novartis receives FDA Breakthrough Therapy designation for ianalumab in Sjögren’s disease, a first potential targeted treatment with dual B-cell depletion and BAFF-R blockade, with global regulatory submissions planned from 2026.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Novartis announced that the US Food and Drug Administration has granted Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease, the second most prevalent rheumatic autoimmune disorder. The decision marks a major regulatory milestone for a condition that still lacks any approved targeted therapy.
Angelika Jahreis, Global Head of Development for Immunology at Novartis, said the designation recognizes the potential of ianalumab to substantially improve the standard of care for patients who currently have limited options. She added that the company will work closely with the FDA to bring the medicine to appropriate patients as quickly as possible.
Breakthrough Therapy
Breakthrough Therapy designation is reserved for medicines that treat serious or life-altering conditions when early clinical evidence indicates a substantial improvement over existing standards of care. In Sjögren’s disease, treatment today remains largely symptomatic, focused on dryness, pain control, and management of complications rather than modifying the underlying immune process.
The designation enables more intensive FDAguidance, rolling review possibilities, and closer collaboration on development plans. Ianalumab had already received Fast Track designation in 2016, and the new status further accelerates the regulatory pathway based on the strength of Phase III data.
Clinical Evidence Supporting the Designation
The FDA decision was supported by positive results from the replicate Phase III trials NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05985915), which evaluated ianalumab in patients with moderate to severe Sjögren’s disease. These pivotal studies demonstrated meaningful improvements in disease activity and patient burden with a safety profile comparable to placebo.
Pharmacally has previously published a detailed analysis of the NEPTUNUS program, including efficacy endpoints, safety findings, and clinical interpretation.
To read full trial coverage Click here
About Ianalumab
Ianalumab represents a new therapeutic approach in autoimmune disease biology. The antibody is designed to act through two complementary pathways:
- Direct depletion of circulating B-cells that drive autoantibody production and tissue inflammation.
- Blockade of BAFF-R signaling, which prevents activation and survival of newly forming pathogenic B-cells.
This dual activity aims to achieve deeper and more durable immune control than approaches that rely on a single mechanism.
Regulatory Outlook
Novartis confirmed that it intends to initiate global submissions from early 2026. The Breakthrough designation in the United States is expected to support faster review timelines and more frequent interaction with the agency on manufacturing, labeling, and post-approval commitments.
About Sjögren’s disease
Sjögren’s disease is a progressive systemic autoimmune condition affecting exocrine glands and multiple organs. Patients commonly experience severe eye and mouth dryness, disabling fatigue, joint and muscle pain, and neurological or pulmonary involvement. The disease also carries an increased risk of lymphoma, highlighting the need for therapies that address immune dysregulation at its source.
The condition affects an estimated 0.25 percent of the global population, yet up to 50 percent of cases remain undiagnosed because of its heterogeneous presentation and overlap with other rheumatic diseases. The absence of targeted options has left clinicians reliant on symptomatic measures, creating a substantial unmet medical need.
References
Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease, 16 January 2026, https://www.novartis.com/news/media-releases/novartis-ianalumab-receives-fda-breakthrough-therapy-designation-sjogrens-disease
Novartis Presents Positive Phase III NEPTUNUS-1 and NEPTUNUS-2 Trial Results for Ianalumab in Sjögren’s Disease, 31 October 2025, https://pharmacally.com/novartis-presents-positive-phase-iii-neptunus-1-and-neptunus-2-trial-results-for-ianalumab-in-sjogrens-disease/
Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients with Active Sjogren’s Syndrome (NEPTUNUS-1), ClinicalTrials.gov ID NCT05350072, https://clinicaltrials.gov/study/NCT05350072
A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients with Sjogrens Syndrome. (NEPTUNUS-Ext), ClinicalTrials.gov ID NCT05985915, https://clinicaltrials.gov/study/NCT05985915