Novartis' ianalumab receives FDA Breakthrough status

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ (NOVN: VX) ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease, the Swiss pharma giant announced late Friday.

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. Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren’s disease. Novartis acquired ianalumab through its $2.9 billion takeover of MorphoSys in 2024.

“This Breakthrough Therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjögren’s disease, who currently don't have effective treatment options for this debilitating disease,” said Angelika Jahreis, global head, development, immunology, Novartis. “We look forward to working with the agency through the regulatory review process with the hope of making ianalumab available to appropriate patients as quickly as possible,” she added.