Novartis today announced that the European Commission (EC) has approved Itvisma® (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene.

With this approval, Itvisma becomes the first and only gene replacement therapy currently approved for this broad SMA population in the European Union.