Novartis receives FDA Breakthrough Therapy designation for ianalumab

Novartis (NVS) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to ianalumab for Sjogren’s disease, the second most prevalent rheumatic autoimmune disease. 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 Sjogren’s disease, the company stated. “This Breakthrough Therapy designation recognizes the potential for ianalumab to substantially improve the standard of care for people with Sjogren’s disease, who currently don’t have effective treatment options for this debilitating disease. 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,” said Angelika Jahreis, Global Head, Development, Immunology, Novartis.