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Drug

Voretigene neparvovec

Approved · EMA

Also known as Luxturna, Recombinant adeno-associated virus retinal pigment epithelium gene vector AAV2-hRPE65v2.

RxNorm1995537UNII2SPI046IKD
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Luxturna (EMA)

Regulatory2018-11-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Voretigene neparvovec
Aliases & brands
LuxturnaRecombinant adeno-associated virus retinal pigment epithelium gene vector AAV2-hRPE65v2
RxNorm CUI
1995537
UNII
2SPI046IKD
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2018-11-22
Latest approval
2018-11-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-11-22Approval
Approval: Luxturna (EMA)
Indication: Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who… Show full indication

Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.