Novartis has received a significant regulatory boost for its autoimmune disease pipeline after the U.S. Food and Drug Administration granted Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease. The decision highlights the therapy’s potential to address a major unmet need in a condition for which no targeted treatments are currently approved.
Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action. It works by depleting B cells while simultaneously inhibiting their activation and survival through blockade of the B-cell activating factor receptor (BAFF-R). This approach is designed to directly target key disease-driving pathways in Sjögren’s disease, which is the second most prevalent rheumatic autoimmune disorder.
The Breakthrough Therapy designation is intended to expedite the development and regulatory review of medicines that show substantial improvement over existing therapies for serious or life-threatening conditions. The designation builds on the Fast Track status ianalumab received in 2016 and is supported by positive results from multiple clinical studies, including replicate Phase III trials. These data suggest ianalumab could meaningfully improve outcomes for patients who currently have limited treatment options.
Novartis said it plans to begin global regulatory submissions for ianalumab in early 2026. If approved, the drug would become the first targeted therapy specifically indicated for Sjögren’s disease, potentially reshaping the treatment landscape for patients and clinicians.
Sjögren’s disease is a chronic, progressive autoimmune condition that can affect multiple organs. Patients often experience persistent dryness, fatigue, and pain, and face an increased risk of developing lymphoma. The disease’s heterogeneous presentation means it is frequently underdiagnosed or misdiagnosed, further delaying appropriate care. Although Sjögren’s affects an estimated 0.25% of the global population, experts believe that as many as half of patients remain undiagnosed.
Novartis emphasized that the FDA’s decision reflects both the strength of the clinical data and the urgent need for effective therapies. Company executives noted that current management options are largely limited to symptomatic relief, underscoring the importance of a targeted treatment that addresses underlying disease mechanisms.
With Breakthrough Therapy designation in place, Novartis will work closely with the FDA to accelerate the review process. The company aims to make ianalumab available to appropriate patients as quickly as possible, offering new hope to individuals living with the long-term burden of Sjögren’s disease.