On January 16, 2026, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational therapy ianalumab (VAY736) for the treatment of Sjögren’s disease, the second most prevalent rheumatic autoimmune disease affecting approximately 0.25% of the population. Sjögren’s is a chronic, progressive, systemic condition characterized by mucosal dryness, fatigue, joint pain, and increased risk of lymphoma, often leading to significant quality-of-life impairment and frequently remaining undiagnosed or misdiagnosed. Currently, no approved targeted therapies exist, leaving patients with limited symptomatic management options.
The Breakthrough Therapy designation expedites the development and regulatory review process for treatments targeting serious conditions with substantial unmet medical needs, especially when preliminary clinical evidence suggests meaningful improvement over available therapies. This follows an earlier Fast Track designation awarded in 2016. The FDA’s decision is supported by robust clinical data, including positive results from multiple studies and replicate global Phase III trials, NEPTUNUS-1 and NEPTUNUS-2. These multicenter, randomized, double-blind, placebo-controlled studies demonstrated that ianalumab (administered subcutaneously at 300 mg monthly or every three months) achieved statistically significant reductions in disease activity, as measured by changes in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) at week 48, alongside clinically meaningful benefits in patient-reported outcomes and reductions in overall disease burden.
Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action: it promotes B-cell depletion through enhanced antibody-dependent cellular cytotoxicity and inhibits B-cell activation and survival by blocking the BAFF receptor (BAFF-R). This targeted approach addresses the core pathophysiology of B-cell hyperactivity in Sjögren’s disease.
In the trials, ianalumab exhibited a favorable safety profile, with adverse event rates comparable to placebo. Angelika Jahreis, Global Head of Development, Immunology at Novartis, stated: “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.” Novartis plans to submit ianalumab for global regulatory approval starting in early 2026. If approved, it would represent the first targeted therapy specifically developed for Sjögren’s patients, marking a major advancement in addressing this long-standing unmet need.
