Core Insights - Novartis announced positive top-line results from Phase III trials for ianalumab (VAY736) in adults with active Sjögren's disease, meeting primary endpoints of statistically significant improvements in disease activity [2][3][8] - Ianalumab has the potential to be the first targeted treatment for Sjögren's disease, a chronic autoimmune condition with limited treatment options [3][8][11] Company Overview - Novartis is focused on innovative medicines, aiming to improve and extend lives, with a global reach impacting nearly 300 million people [13] - The company plans to present data from the NEPTUNUS trials at a medical meeting and submit ianalumab to health authorities worldwide [4][8] Product Details - Ianalumab is a fully human monoclonal antibody targeting B cell-driven autoimmune diseases, including Sjögren's disease, with a dual mechanism of action [5][11] - The drug demonstrated a favorable safety profile and was well tolerated in clinical trials [3][8] Clinical Trial Information - NEPTUNUS-1 and NEPTUNUS-2 are pivotal Phase III trials evaluating ianalumab's efficacy and safety in patients with active Sjögren's disease [6][7] - NEPTUNUS-1 involved 275 patients, while NEPTUNUS-2 included 504 patients, both trials assessing the drug's impact over 52 weeks [7][9] Disease Context - Sjögren's disease is a prevalent autoimmune disorder affecting approximately 0.25% of the population, with a significant number of cases undiagnosed [11] - The disease primarily affects exocrine glands, leading to symptoms like dry eyes and mouth, and can involve extraglandular manifestations [10][11]