India Pharma Outlook Team | Monday, 19 January 2026
Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjogren’s disease, marking a major step for patients with limited treatment options.
The decision highlights the promise of ianalumab to change care in the second most common rheumatic autoimmune disease. Novartis plans to begin global regulatory submissions in early 2026. If approved, ianalumab would become the first targeted therapy for this condition.
Also Read: Advancing Interventional Radiology in India Through Collaboration
“This Breakthrough Therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjogren’s disease, who currently don't have effective treatment options for this debilitating disease,” said Angelika Jahreis, global head, development, immunology, Novartis. “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.”
Ianalumab is a fully human monoclonal antibody with a dual action. It depletes B-cells and blocks their activation and survival through BAFF-R inhibition. The designation builds on the Fast Track status the FDA granted the drug in 2016 and is backed by strong data from multiple studies, including replicate phase III trials.
Sjögren’s disease is a serious, progressive autoimmune disorder that can affect many organs. Patients often live with dryness, fatigue, pain, and a higher risk of lymphoma. About 0.25% of the population is affected, and nearly half remain undiagnosed, often due to misdiagnosis.
The global NEPTUNUS-1 and NEPTUNUS-2 trials showed that ianalumab improved disease activity and reduced patient burden. Safety results were favorable, with adverse events comparable to placebo, reinforcing its potential as a new standard of care.
.jpg)
.jpg)
