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# Novartis Wins Breakthrough Status for Ianalumab
- URL: https://www.fdaweb.com/novartis-wins-breakthrough-status-for-ianalumab/
- Published: 2026-01-16T12:00:00.000Z
- Updated: 2026-09-14T15:30:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160505

FDA has granted Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogren’s disease, a move that could speed development and regulatory review for a condition with no approved targeted therapies. The designation was based on clinical data from multiple studies, including replicate Phase 3 trials, showing that ianalumab has the potential to offer a meaningful improvement over existing care, Novartis says. The company plans to begin submitting the drug for regulatory approval to health authorities worldwide starting soon.

If approved, ianalumab would become the first targeted treatment for Sjogren’s disease, a chronic autoimmune condition that affects multiple organs and is marked by symptoms such as severe dryness, fatigue and pain. The monoclonal antibody is designed with a dual mechanism of action that both depletes B cells and blocks their activation and survival through inhibition of the BAFF receptor pathway, the company says.