Novartis ianalumab receives FDA breakthrough therapy designation for Sjögren’s disease

Novartis

16 January 2026 - Novartis today announced that the US FDA has granted breakthrough therapy designation to ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease. 

Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade.

Read Novartis press release

Michael Wonder

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Michael Wonder