Novartis Lands US FDA Breakthrough Therapy Classification for Ianalumab in Sjögren's Disease

12:35 AM EST, 01/18/2026 (MT Newswires) -- Novartis (NOVN.SW) said its ianalumab medicine received the breakthrough therapy designation from the US Food and Drug Administration for Sjögren's disease. Following the award of the fast-track designation in 2016, the latest distinction is based on positive data from multiple studies, including replicate phase 3 trials Neptunus-1 and Neptunus-2, according to a Jan. 16 release. The studies showed an improvement in disease activity and a decline in patient burden, with a favorable safety profile for Ianalumab. The Swiss drugmaker aims to seek regulatory approval for ianalumab globally from early 2026, making it the first targeted treatment for patients with the rheumatic autoimmune disease.