
2 July 2026 - Novartis today announced that the European Commission has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy with a bi-allelic mutation in the survival motor neuron 1 gene.
With this approval, Itvisma becomes the first and only gene replacement therapy currently approved for this broad SMA population in the European Union.