Health
Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease
Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1Distinction expedites development and review of treatments for serious conditions that may demonstrate improvement over standard of careNovartis plans to submit to health authorities globally starting in early 2026Ianalumab has potential to become first targeted treatment for this autoimmune disease with significant unmet need Basel, January 16, 2026 – Novartis today announce
About this update from Novartis Ag
[{"type":"image","alt":"Novartis Pharma AG","displaySize":"","headline":null,"caption":"Novartis Pharma AG","className":"","disableSlideshowImg":false,"size":{"original":{"width":287,"height":55,"url":"https://media.zenfs.com/en/globenewswire.com/838a2f0cbe482ce95bb28a161721a308"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/jVHT.jc1r.9_PBg7JQVa4A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTgwO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/838a2f0cbe482ce95bb28a161721a308","width":287,"height":55}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1","length":122,"tagName":"p"}]},{"val":[{"type":"text","content":"Distinction expedites development and review of treatments for serious conditions that may demonstrate improvement over standard of care","length":136,"tagName":"p"}]},{"val":[{"type":"text","content":"Novartis plans to submit to health authorities globally starting in early 2026","length":78,"tagName":"p"}]},{"val":[{"type":"text","content":"Ianalumab has potential to become first targeted treatment for this autoimmune disease with significant unmet need","length":114,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":450,"olType":false},{"type":"text","content":"Basel, January 16, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease2. Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade3. Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren’s disease.“This Breakthrough Therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjögren’s disease, who currently don't have effective treatment options for this debilitating disease,” said Angelika Jahreis, Global Head, Development, Immunology, Novartis. “We look forward to working with the agency through the regulatory review process with the hope of making ianalumab a...