Proper Name: voretigene neparvovec-rzyl
Trade Name: LUXTURNA
Manufacturer: Spark Therapeutics, Inc.
- For the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
- Package Insert - LUXTURNA
- Demographic Subgroup Information - voretigene neparvovec [LUXTURNA]
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- June 8, 2022 Approval Letter - LUXTURNA
- December 19, 2017 Approval Letter - LUXTURNA
- December 18, 2017 Summary Basis for Regulatory Action - LUXTURNA
- Approval History, Letters, Reviews, and Related Documents - LUXTURNA