The FDA has granted Breakthrough Therapy designation to Novartis’ ianalumab for Sjögren’s disease, marking a key regulatory step toward what could become the first targeted treatment for the condition.
Novartis 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 disease. 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 blockade. 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.
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“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 available to appropriate patients as quickly as possible.”
Building on the Fast Track designation that ianalumab was awarded in 2016, the FDA Breakthrough Therapy designation aims to expedite the development and review of therapies intended to treat serious conditions and address significant unmet needs. Awarding of the Breakthrough Therapy designation is supported by positive data from multiple studies, including replicate phase III trials.
Sjögren’s disease is a serious, progressive, autoimmune condition that affects multiple organs causing a wide spectrum of symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma, which can carry a significant burden and impact on quality of life. Its heterogenous nature often causes it to go unrecognized or misdiagnosed. Sjögren’s affects approximately 0.25% of the population, and it is estimated that 50% of people with Sjögren’s are undiagnosed. There are no approved targeted treatments available for Sjögren’s disease.
