Novartis announced that the US FDA has granted breakthrough therapy status to ianalumab for Sjögren's disease, the second most common rheumatic autoimmune disease.[2][1] The status was granted based on positive results from two phase 3 clinical trial programs.[1][2] Ianalumab is a fully human monoclonal antibody drug with a dual mechanism of action that depletes B cells and blocks their activation via BAFF-R.[2] In the NEPTUNUS trials, ianalumab significantly reduced disease activity as measured by the ESSDAI index compared to placebo as early as week 16, with the effect maintained through week 52.[3][2] The drug improved secondary outcomes, such as low disease activity, physician assessment, patient global assessment, and symptoms of dryness, pain, and fatigue.[3] Ianalumab showed a favorable safety profile with an incidence of adverse events comparable to placebo.[2][1] Novartis plans to file registration applications with regulatory authorities worldwide beginning in early 2026.[2] If approved, it would become the first targeted treatment for Sjögren's disease.[2]