Novartis Introduces Breakthrough Ianalumab for the Treatment of Sjögren’s Disease
Novartis has introduced ianalumab for the treatment of patients with Sjögren’s disease, a chronic autoimmune condition that affects the body’s moisture-producing glands and can involve multiple organs.
Ianalumab is a fully human monoclonal antibody designed with a dual mechanism of action that targets B-cells. The therapy works by depleting B-cells and blocking the BAFF receptor, which helps inhibit the activation and survival of these immune cells involved in the disease process. If approved, ianalumab could become the first targeted treatment specifically developed for patients with Sjögren’s disease.
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to ianalumab based on positive clinical findings from several studies, including replicate Phase III trials. The designation is intended to accelerate the development and review of investigational therapies that may provide substantial improvement over existing treatment options for serious conditions with significant unmet medical need.
The therapy had previously received Fast Track designation from the FDA in 2016. Novartis plans to begin global regulatory submissions for ianalumab in early 2026 as part of its efforts to bring the therapy to patients.
Sjögren’s disease is a progressive autoimmune disorder that can affect various organs and is commonly associated with symptoms such as dryness, fatigue and pain. The condition may also increase the risk of complications, including lymphoma. Due to its complex and varied symptoms, the disease is often underdiagnosed or misdiagnosed. It is estimated to affect around 0.25 per cent of the population, with a significant proportion of cases remaining undetected. Currently, there are no approved targeted therapies specifically for this condition.
The Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, are global multicentre studies evaluating the safety and effectiveness of ianalumab in patients with Sjögren’s disease. Results from both trials have shown clinically meaningful improvements in disease activity and reductions in patient burden. The therapy also demonstrated a favourable safety profile, with rates of adverse and serious adverse events comparable to placebo.
