$NVS

Novartis announced that the CHMP of the European Medicines Agency has issued a positive opinion recommending marketing authorization for Itvisma (intrathecal onasemnogene abeparvovec) for the treatment of children, teens, and adults with 5q spinal muscular atrophy (SMA). This gene replacement therapy is designed to address the genetic root cause of SMA by replacing the SMN1 gene, potentially reducing the need for chronic treatment. The recommendation is based on data from the STEER, STRENGTH, and STRONG studies, which demonstrated statistically significant and clinically meaningful improvements in motor function.