LUXTURNA

STN: 125610
Proper Name: voretigene neparvovec-rzyl
Trade Name: LUXTURNA
Manufacturer: Spark Therapeutics, Inc.

Product Information

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• For the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Product Information

• 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.

Product Information

Supporting Documents

• 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

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