Recognition from U.S. regulatory authorities On January 19, 2026, the U.S. Food and Drug Administration (FDA) officially granted “Breakthrough Therapy” designation to Novartis’ ianalumab. This candidate targets Sjögren’s disease, a chronic and progressive autoimmune disorder that currently lacks any approved targeted therapies worldwide. This designation is intended to expedite clinical development and accelerate the regulatory review process.
Mechanism of action and clinical efficacy Ianalumab is a fully human monoclonal antibody featuring a unique dual mechanism of action:
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Mode of operation: The drug simultaneously depletes pathogenic B cells and inhibits their activation and survival by blocking the BAFF receptor (BAFF-R).
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Clinical data: The FDA’s decision is supported by positive evidence from the global Phase III NEPTUNUS-1 and NEPTUNUS-2 trials. In these studies, ianalumab demonstrated clinically meaningful improvements in disease activity and a reduction in patient burden, with a safety profile comparable to that of a placebo.
Market access outlook Novartis plans to initiate global regulatory submissions for ianalumab starting in early 2026. If approved, it has the potential to become the first targeted therapy specifically indicated for Sjögren’s disease. The condition currently affects approximately 0.25% of the global population, causing severe symptoms such as gland dryness, chronic fatigue, and an increased risk of lymphoma. Currently, nearly half of those affected remain undiagnosed due to the disease’s complex and heterogeneous presentation.