voretigene neparvovec-rzyl

FDA Drug Profile — LUXTURNA

Drug Details

Generic Name
voretigene neparvovec-rzyl
Brand Names
LUXTURNA
Application Number
BLA125610
Sponsor
Spark Therapeutics, Inc.
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s). LUXTURNA is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s). ( 1 )