Novartis' Ianalumab Meets Phase III Endpoints in Sjögren's Disease Trials

Novartis announced that its drug candidate ianalumab met the primary endpoints in two Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, for treating adults with active Sjögren's disease, a chronic systemic autoimmune disorder. Both studies demonstrated statistically significant improvements in disease activity and confirmed ianalumab's favorable safety profile and tolerability. Ianalumab utilizes a dual mechanism of action by combining B-cell depletion with BAFF-R inhibition to target the underlying immune dysfunction in patients. The drug has received Fast Track designation from the US FDA, reflecting the urgent need for effective treatments for this progressive disease, and Novartis plans to submit it for regulatory approval globally. These results mark a major advance toward the first targeted therapy for Sjögren's disease, potentially improving quality of life for patients who currently have limited treatment options. Novartis will present detailed data at forthcoming medical conferences to support its regulatory submissions.