HQ Team
August. 11, 2025: Novartis AG announced positive Phase III trial results for its experimental autoimmune drug, Ianalumab (VAY736), in treating Sjögren’s syndrome, marking a significant step forward for the Swiss drugmaker in addressing this chronic autoimmune disease.
Sjögren’s Disease
Sjögren’s syndrome is a chronic autoimmune disease that primarily affects the moisture-producing glands, causing dry eyes and mouth. It can also impact other organs, leading to fatigue and pain. Approximately 4 million people globally are affected, with many cases remaining undiagnosed. Currently, there are no approved systemic treatments, and patients often rely on symptomatic relief.
Ianalumab (VAY736), developed by Novartis, is a novel monoclonal antibody designed to treat Sjögren’s disease. It works by depleting B cells and blocking BAFF-R signals, which play a key role in the disease. Recent Phase III trials showed significant improvements in disease activity and a favorable safety profile, positioning Ianalumab as the first targeted treatment for this condition.
The NEPTUNUS-1 and NEPTUNUS-2 trials for the disease involved over 700 patients and measured improvements in disease activity using the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). Both trials achieved their primary endpoints, demonstrating statistically significant reductions in ESSDAI scores. The drug was well-tolerated, with no serious safety concerns identified.
“Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognized or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need. Both Phase III trials demonstrate that Ianalumab improves disease activity in patients with Sjogren’s disease,” said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis.
Market Potential: Capturing a $10B+ Opportunity
With no approved treatments currently available, the market potential for Sjögren’s disease therapies is significant. Analysts estimate the market could reach over $10 billion by 2030. Novartis’s Ianalumab, with its promising trial results and orphan drug designation, is well-positioned to capture a substantial share of this market.
Ianalumab is being developed to treat other autoimmune disorders including lupus as the company seeks to boost growth, and analysts estimate it could become a blockbuster. Competitors including Sanofi and Roche are also developing therapies for these conditions.
Novartis’s global infrastructure and experience in drug development and commercialization provide a strong foundation for the successful launch of Ianalumab. The company’s acquisition of MorphoSys AG in 2024 further strengthened its research capabilities.
Novartis plans to present the NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical meeting and submit Ianalumab, which was granted Fast Track Designation by the US Food and Drug Administration (FDA), to health authorities globally.
