Core Insights - Novartis announced positive top-line results from Phase III trials for ianalumab (VAY736) in adults with active Sjögren's disease, indicating potential as the first targeted treatment for this chronic autoimmune condition [2][3][8] Company Overview - Novartis is an innovative medicines company focused on improving and extending lives through advanced medical solutions, reaching nearly 300 million people globally [13] Product Details - Ianalumab (VAY736) is a fully human monoclonal antibody targeting B cell-driven autoimmune diseases, including Sjögren's disease, with a dual mechanism of action involving B-cell depletion and BAFF-R inhibition [5][6] - The drug has shown promising efficacy and a favorable safety profile in clinical trials for Sjögren's disease and other autoimmune conditions [5][8] Clinical Trials - The NEPTUNUS-1 and NEPTUNUS-2 trials are pivotal Phase III studies evaluating the efficacy and safety of ianalumab in patients with active Sjögren's disease, achieving significant improvements in disease activity as measured by the ESSDAI index [6][7][9] - NEPTUNUS-1 involved 275 patients, while NEPTUNUS-2 included 504 patients, both trials demonstrating statistically significant reductions in disease activity compared to placebo [7][8] Market Potential - Ianalumab has the potential to become the first and only targeted treatment approved for Sjögren's disease, addressing a significant unmet medical need in a condition that affects approximately 0.25% of the population, with many cases undiagnosed [11][8]