Novartis’ ianalumab moves a step closer to approval in Sjögren’s disease with FDA Breakthrough Therapy designation | iPharmaCenter
- Badari Andukuri
- 1 day ago
- 2 min read
Novartis has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational medicine ianalumab for the treatment of Sjögren’s disease, a systemic rheumatic autoimmune condition that ranks among the most common in its class.
About ianalumab and its mechanism of action
Ianalumab is a fully human monoclonal antibody engineered with a dual mechanism that both depletes B cells and blocks their activation and survival through inhibition of the BAFF receptor, a pathway thought to be central to the disease process.
The company intends to begin filing ianalumab with regulatory agencies worldwide from early 2026, with the goal of making it the first targeted therapy specifically approved for Sjögren’s disease if authorization is granted.
The new status builds on the Fast Track designation ianalumab received in 2016 and is designed to speed the development and review of therapies for serious conditions where existing options are limited or inadequate.
About Sjögren’s disease
Sjögren’s disease is a chronic, progressive autoimmune disorder that can involve numerous organs and systems, leading to symptoms such as dryness, profound fatigue, pain, and a heightened risk of lymphoma, all of which can significantly impair quality of life. Because the disease presents with a broad and variable pattern of manifestations, it is frequently under‑recognized or misattributed to other conditions, contributing to diagnostic delays and under‑diagnosis.
Epidemiologic estimates suggest that roughly a quarter of a percent of the population is affected, and about half of those living with Sjögren’s may not yet have a formal diagnosis, while no targeted therapies have been approved to date.
Clinical trials of ianalumab in Sjögren’s diseasegren
The pivotal phase III NEPTUNUS‑1 and NEPTUNUS‑2 trials are global, multicenter studies designed to evaluate the efficacy and safety of ianalumab in adults with active Sjögren’s disease. In these trials, ianalumab achieved clinically meaningful benefits, with statistically significant reductions in disease activity and improvements in patient burden compared with placebo, and met primary endpoints based on the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
Across both studies, the safety profile of ianalumab was described as favorable, with overall rates of adverse events and serious adverse events generally similar to those observed in the placebo groups.
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