Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment for Sjögren’s disease, the second most prevalent rheumatic autoimmune condition.
Ianalumab is a fully human monoclonal antibody that targets B-cells and inhibits their activation and survival by blocking B-cell activating factor receptor (BAFF-R).
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Novartis intends to submit ianalumab for regulatory approval globally in early 2026. If approved, it would represent the first targeted therapy available for patients with Sjögren’s disease.
Ianalumab received fast track designation in 2016. The breakthrough therapy designation from the FDA aims to accelerate the development and review of therapies addressing serious conditions and unmet medical needs.
The latest FDA recognition is supported by positive results from several studies, including two replicate Phase III trials.
Sjögren’s disease is a progressive autoimmune disorder that impacts multiple organs, causing symptoms such as pain, fatigue, dryness, and an elevated risk of lymphoma.
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By GlobalDataThis disease can impose significant burdens on quality of life. Its heterogeneity often leads to underrecognition or misdiagnosis. Nearly 0.25% of the population is affected, with half estimated to be undiagnosed. Currently, there are no approved targeted therapies for this condition, said Novartis.
The Phase III NEPTUNUS-1 and NEPTUNUS-2 clinical trials are pivotal, global studies assessing the safety and efficacy of ianalumab in patients with Sjögren’s disease. In both trials, ianalumab provided clinically meaningful improvements in disease activity and reductions in patient burden. The safety profile was favourable, with adverse event rates similar to placebo.
Novartis development, immunology global head Angelika Jahreis said: “This breakthrough therapy designation recognises 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.
“We look forward to working with the agency through the regulatory review process with the hope of making ianalumab available to appropriate patients as quickly as possible.”
In January 2026, Novartis announced plans to build a radioligand therapy (RLT) manufacturing facility in Winter Park, Florida, as part of its ongoing expansion plan.
