Novartis announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjogren's disease, the second most prevalent rheumatic autoimmune disease2. Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that inhibits B-cells and inhibits their activation and survival via BAFF-R blockade3. Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026.
Building on the Fast Track designation that ianalumab was awarded in 2016, the FDA Breakthrough Therapy designation aims to expedite the development and review of therapies intended to treat serious conditions and address significant unmet needs4. Awarding of the Breakthrough Therapy designation is supported by positive data from multiple studies, including replicate phase III trials. There are no approved targeted treatments available for Sjogren's Disease.
The ianalumab Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, are global, multicenter, pivotal studies evaluating the efficacy and safety of ianalumab in patients with Sjogren's disease10,11. In both trials, ianalumab delivered a clinically meaningful benefit, showing improvement in disease activity and reductions in patient burden.
