Luxturna (voretigene neparvovec)
OrphanATMPAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- voretigene neparvovec
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Leber Congenital Amaurosis; Retinitis Pigmentosa
- CHMP opinion
- Thu 20 Sep 2018
- EU approval
- Thu 22 Nov 2018
- Designations
- Orphan, ATMP, Additional monitoring
- Application
- EMEA/H/C/004451
- ATC
- S01XA27
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.