Novartis has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease, a chronic and progressive autoimmune disorder with significant unmet medical need.
The designation is supported by clinical evidence, including positive data from replicate Phase III trials, and is intended to accelerate the development and regulatory review of therapies that may offer substantial improvement over existing standards of care.
Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that both depletes B cells and inhibits their activation and survival through BAFF receptor (BAFF-R) blockade. Novartis plans to begin regulatory submissions for ianalumab with health authorities worldwide starting in early 2026. If approved, it has the potential to become the first targeted therapy specifically indicated for Sjögren’s disease.
The Breakthrough Therapy designation builds on the Fast Track status previously granted to ianalumab and reflects the seriousness of Sjögren’s disease, which affects multiple organ systems and is associated with symptoms such as severe dryness, fatigue, pain, and an increased risk of lymphoma.
The condition is often underdiagnosed due to its heterogeneous presentation, with an estimated prevalence of around 0.25% globally and nearly half of affected individuals remaining undiagnosed. Currently, there are no approved targeted treatments for the disease.
The designation is underpinned by results from the global Phase III NEPTUNUS-1 and NEPTUNUS-2 trials, which evaluated the efficacy and safety of ianalumab in patients with Sjögren’s disease. Across both studies, ianalumab demonstrated clinically meaningful improvements in disease activity and reductions in patient burden, with a safety profile comparable to placebo in terms of overall and serious adverse events.
With this regulatory milestone, ianalumab moves closer to potentially addressing a long-standing treatment gap for patients living with Sjögren’s disease.
