A new era in the treatment of Sjögren’s syndrome is beginning. The FDA has granted “Breakthrough Therapy” designation to ianalumab, a drug developed by Novartis. This monoclonal antibody was specifically engineered for the treatment of Sjögren’s syndrome and is currently undergoing the decisive stage of clinical trials.
This decision is based on the impressive results of the Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2. The 48-week testing period confirmed that, compared to placebo, the drug effectively reduces disease activity (according to the ESSDAI scale).
Despite Sjögren’s syndrome being one of the most prevalent autoimmune pathologies, it often remains undiagnosed. Consequently, a portion of patients is left without adequate management. The emergence of ianalumab represents the first step toward establishing specific, targeted therapy for Sjögren’s syndrome.
The efficacy of ianalumab is driven by its innovative, dual-action mechanism: the drug blocks the B-cell activating factor receptor (BAFF-R), which ensures the depletion of B-cells and prevents their activation. This high-tech therapy will be available to patients in the form of a simple subcutaneous injection.
Novartis plans to submit applications to regulatory bodies by the beginning of 2026. Upon authorization, ianalumab will become the first targeted therapy designed specifically for the management of Sjögren’s syndrome.
Angelika Jahreis, Global Head of Development in Immunology at Novartis, stated that the FDA’s decision confirms ianalumab’s unique potential to radically transform the management of Sjögren’s syndrome.
This achievement guarantees an improved quality of life for patients, which, alongside overcoming pain and fatigue, implies the prevention of severe complications. Furthermore, the success of ianalumab may prove pivotal for the management of other B-cell-mediated autoimmune diseases as well.
Source: Novartis
