ITVISMA

STN: BL 125856/0 Proper Name: onasemnogene abeparvovec-brve Tradename: ITVISMA Manufacturer: Novartis Gene Therapies, Inc. Indication: For the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene. Product Information Package Insert and Medication Guide - ITVISMA Supporting Documents November 24, 2025 Approval Letter - ITVISMA