FDA Grants Breakthrough Therapy Designation to Novartis Ianalumab for Sjögren’s Disease

Reuters
2026.01.16 17:00
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Novartis AG has received Breakthrough Therapy designation from the FDA for ianalumab, aimed at treating Sjögren’s disease. This designation is based on phase III trial results indicating its potential to meet significant unmet medical needs. Novartis plans to seek global regulatory approval for ianalumab starting in early 2026, which could make it the first targeted treatment for this autoimmune condition.