Novartis (NYSE:NVS) announced significant breakthrough in Phase III clinical trials for ianalumab in treating Sjögren's disease. Both NEPTUNUS-1 and NEPTUNUS-2 trials met their primary endpoint, demonstrating statistically significant improvements in disease activity measured by EULAR Sjögren's syndrome disease activity index (ESSDAI).
Ianalumab, which features a dual mechanism of action through B-cell depletion and BAFF-R inhibition, could become the first targeted treatment approved for Sjögren's disease. The drug demonstrated a favorable safety profile and was well-tolerated in trials. Having received FDA Fast Track Designation, Novartis plans to present detailed trial data at an upcoming medical meeting and submit to health authorities globally.
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