Reported Earlier: Novartis Receives European Commission Approval For Itvisma To Treat Children With 5q Spinal Muscular Atrophy

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.