Novartis received breakthrough therapy designation from the FDA for ianalumab, a monoclonal antibody aimed at treating Sjögren’s disease.
Ianalumab works by depleting B cells and blocking BAFF-R signaling, which inhibits B-cell activation and survival. The drugmaker, based in Switzerland, plans to begin global regulatory submissions in early 2026, according to a Jan. 16 company news release. If approved, ianalumab would become the first targeted treatment for Sjögren’s, a systemic autoimmune disorder with no approved therapies.
The FDA’s designation is based on results from two global phase 3 trialsthat demonstrated clinically meaningful benefits, reduced disease burden and a favorable safety profile. Ianalumab previously received fast track designation in 2016, the release said.
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