Novartis ianalumab first drug to reduce disease activity and patient burden in Sjögren’s disease Phase III trials

Core Insights - Novartis presented new data on ianalumab for Sjögren's disease, highlighting its potential to significantly improve disease activity and reduce patient burden in Phase III trials [1][2][4] Clinical Trial Results - Ianalumab 300 mg monthly showed a clinically meaningful benefit in the NEPTUNUS-1 and NEPTUNUS-2 Phase III trials, with a greater reduction in disease activity compared to placebo, sustained through Week 52 [2][4] - Statistically significant improvement in the primary endpoint, ESSDAI, was observed at Week 48, with numerical improvements noted as early as Week 16 [4][5] - Secondary outcome measures also showed consistent numerical improvements, including physician- and patient-reported outcomes, although some did not reach statistical significance [5][7] Mechanism of Action - Ianalumab is a fully human monoclonal antibody that depletes B-cells and inhibits their activation and survival via BAFF-R blockade, addressing the B-cell dysfunction central to Sjögren's disease [3][9] Future Plans - Novartis plans to submit ianalumab for regulatory approval globally in early 2026, aiming to establish it as the first targeted treatment for Sjögren's disease [5][4] Disease Overview - Sjögren's disease is a systemic autoimmune condition affecting approximately 0.25% of the population, with a higher prevalence in women, leading to significant symptoms such as dryness, fatigue, and pain [10]