Ianalumab Phase III clinical trials meets primary endpoint in patients with Sjögren’s disease

Novartis has recently announced their positive top-line results from its Phase III trials evaluating ianalumab in adults with active Sjögren’s disease. Both of the 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 Sjögren’s disease, a chronic, disabling autoimmune disease.

“Sjögren’s disease is a serious, progressive, systemic autoimmune disease, often unrecognized or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need. Both Phase III trials demonstrate that ianalumab improves disease activity in patients with Sjogren’s disease.” said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. “These Phase III studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings in the near future.”

Note that the NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren’s syndrome disease activity index, a multi-dimensional disease activity measurement compared to placebo.

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Related Topics and Keywords

ianalumab, Novartis, novrtis, Phase III clinical trials, Sjögren’s disease