Novartis announces both ianalumab trials met primary endpoint

Novartis (NVS) announced top-line results from its Phase III trials evaluating ianalumab in adults with active Sjogren’s disease. Both trials met the primary endpoint of demonstrating statistically significant improvements in disease activity. These results support the potential for ianalumab, a drug with a dual mechanism of action, B-cell depletion and BAFF-R inhibition, to become the first targeted treatment for patients with Sjogren’s disease, a chronic, disabling autoimmune disease. The NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjogren’s syndrome disease activity index, a multi-dimensional disease activity measurement compared to placebo. Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjogren’s disease. Novartis plans to present the NEPTUNUS-1 and NEPTUNUS-2 data at an upcoming medical meeting and submit ianalumab, which was granted Fast Track Designation by the FDA, to health authorities globally.