onasemnogene abeparvovec-brve

FDA Drug Profile — ITVISMA

Drug Details

Generic Name
onasemnogene abeparvovec-brve
Brand Names
ITVISMA
Application Number
BLA125856
Sponsor
Novartis Gene Therapies, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SUSPENSION
Routes
INTRATHECAL
Active Ingredients
ONASEMNOGENE ABEPARVOVEC

Indications and Usage

1 INDICATIONS AND USAGE ITVISMA is indicated 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. ITVISMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in SMN1 gene. ( 1 )