Regulatory recognition On January 19, 2026, the U.S. Food and Drug Administration (FDA) officially granted “Breakthrough Therapy” designation to ianalumab, a promising candidate for the treatment of Sjögren’s disease. Despite being the second most prevalent rheumatic autoimmune condition, Sjögren’s currently has no approved targeted therapies worldwide. This designation is intended to expedite the development and regulatory review process for the drug.
Dual mechanism of action and clinical results Ianalumab is a fully human monoclonal antibody with a unique dual mechanism targeting B-cells, the key drivers of autoimmune responses:
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Mechanism: The drug simultaneously depletes pathogenic B-cells and inhibits their activation by blocking the BAFF receptor (a factor essential for B-cell survival).
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Efficacy: Results from two pivotal Phase III trials (NEPTUNUS-1 and NEPTUNUS-2) demonstrated that ianalumab significantly reduced disease activity as measured by the ESSDAI index and improved patient quality of life compared to placebo.
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Safety: The safety profile was favorable, with adverse event rates comparable to those of the placebo group across 52-week studies.
Commercialization roadmap Novartis intends to submit ianalumab for regulatory approval to global health authorities in early 2026. If approved, it would become the first-ever targeted therapy available for millions of Sjögren’s patients, who currently manage chronic symptoms such as debilitating fatigue, gland dryness, and an elevated risk of lymphoma. It is currently estimated that approximately 50% of people with the disease remain undiagnosed due to the complexity and heterogeneity of its symptoms.
Source: https://www.pharmaceutical-technology.com/news/fda-novartis-ianalumab-breakthrough-status/