Novartis receives FDA approval for Itvisma®, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)

Ad hoc announcement pursuant to Art. 53 LR Itvisma (onasemnogene abeparvovec-brve) demonstrated improved motor function and stabilization in patients regardless of SMA treatment history in Phase III studiesOne-time dose of Itvisma replaces SMN1 gene, potentially reducing the need for chronic SMA treatmentGene replacement therapy now available to eligible people of all ages living with SMA Basel, November 24, 2025 – Novartis today announced that the US Food and Drug Administration (FDA) has approved Itvisma® ...