Afshan Arjumand Ianalumab received Food and Drug Administration (FDA) Breakthrough Therapy designation for Sjögren’s disease, the 2nd most common rheumatic autoimmune disorder. Ianalumab is a fully human mAb with unique dual mechanism of action that depletes β-cells and prevents activation and survival of β-cells via BAFF-R blockade. Novartis will submit for regulatory approval of ianalumab globally beginning in early 2026. If approved, it would be the 1st targeted therapy available to treat Sjögren’s disease. “The Breakthrough Therapy designation demonstrates our belief that Ianalumab has the promise to significantly improve the standard of care for those living with Sjögren’s disease, which currently does not provide sufficient options for treatment,” said Angelika Jahreis, Global Head of Development, Immunology, Novartis. “We are eager to work together with the FDA to move through the regulatory review process to provide an opportunity to eligible patients in a timely manner.” Ianalumab received Fast Track designations from the FDA in 2016 and has now been awarded Breakthrough Therapy designation as well, to expedite both development and review of therapies for serious diseases with unmet needs. The Breakthrough Therapy designation will be granted based on favorable data from many studies, including replicated phase III studies. Sjögren’s Syndrome is a serious autoimmune disease that interferes with many organ systems and can lead to a variety of clinical symptoms as well as severe complications from a high rate of lymphoma and other side effects from prescribed treatments or poor disease control. Sjögren’s Syndrome affects about 0.25% of people, and approximately 50% of people with the disease do not know it (and many more do not have accurate information about the condition). There are currently no approved treatments to target this disease. The ianalumab Phase III studies NEPTUNUS-1 and NEPTUNUS-2 are pivotal trials being conducted throughout the world that will study the effectiveness and safety of ianalumab for patients with Sjögren’s syndrome. Both studies showed that Ianalumab is effective in treating patients with clinically meaningful improvement in the activity of their disease and decreased patient burden. The safety profile of ianalumab was comparable to placebo, leading to a low incidence of adverse events and serious adverse events in both of the pivotal clinical trials. Reference: Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease, Novartis, Jan 16, 2026.