Briefs · Frontier Science
Sjögren's Finally Has a Treatment in Sight
Sjögren’s disease finally has a treatment in sight — and the FDA has noticed.
On 16 January, the US Food and Drug Administration granted Breakthrough Therapy designation to ianalumab, Novartis’s monoclonal antibody for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease. There is, at present, no targeted treatment for it at all.
Ianalumab is a fully human monoclonal antibody with a dual mechanism. It depletes B-cells and blocks their activation and survival through BAFF-R. B-cells depleted, activation denied: two blows to the same misbehaving system.
The designation rests on NEPTUNUS-1 and NEPTUNUS-2, the first global Phase III trials to show a statistically significant improvement in ESSDAI, the standard measure of Sjögren’s disease activity. Novartis plans to submit for approval globally from early 2026. If approved, ianalumab would be the first targeted treatment for the disease.
The path is not new. Ianalumab already carried a Fast Track designation from 2016. Ten years of patience, and now a breakthrough label to show for it.
Conclusion: ianalumab is not another me-too antibody, but rather the first targeted answer to a disease that had none.
Summary in our own words. The original belongs to its publisher.