Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Basel, April 24, 2026 – Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Itvisma® (intrathecal onasemnogene abeparvovec). The opinion supports its use 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.