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Ianalumab, an investigational fully human monoclonal antibody drug being studied for its potential to treat various B cell-driven autoimmune diseases, received a Breakthrough Therapy designation for Sjögren disease from the FDA, according to a press release from its developer, Novartis.
Ianalumab has a distinct mechanism of action in that it uses B-cell activating factor receptor blockade to deplete B cells and impede both their survival and activation.
Looking ahead, Novartis is seeking global approval of ianalumab. If granted, this global approval would make ianalumab the first targeted therapy for the management and care of Sjögren disease.
This Breakthrough Therapy designation is based on the results of NEPTUNUS-1 and NEPTUNUS-2, which are multicenter, phase 3 clinical trials. The NEPTUNUS-1 and NEPTUNUS-2 trials were specifically designed to evaluate changes in European League Against Rheumatism Sjögren’s syndrome disease activity index (ESSDAI) from baseline to week 48 in patients receiving ianalumab vs placebo.
The outcomes for the trials were presented at the American College of Rheumatology (ACR) 2025 Annual Meeting in October.
The results presented there on NEPTUNUS-1 highlighted trends in ESSDAI score from baseline to week 48, showing a drop of 6.4 vs 5.1 points with ianalumab vs placebo.
Other data presented on NEPTUNUS-2 also looked at outcomes between baseline and week 48, with a reported ESSDAI score decline of 6.5 vs 5.5 points with ianalumab vs placebo.
All in all, these research outcomes showed that ianalumab use led to a clinically significant decline in patient burden and better overall disease activity. When it came to safety and overall prevalence of adverse events, the results from both investigations indicated that ianalumab had similar outcomes to placebo.
Previously, the FDA granted ianalumab a fast-track designation in 2016.
