Shots:
The US FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of pts (≥2yrs.) living with spinal muscular atrophy (SMA) harboring a confirmed mutation in the SMN1 gene; US availability expected in Dec 2025
Approval was based on the P-III (STEER) trial & open-label P-IIIb (STRENGTH) study, showing Itvisma improved motor function & stabilized…
