LUXTURNA (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
LUXTURNA
Date registered
Evaluation commenced
Decision date
Approval time
208 working days (255)
Active ingredients
voretigene neparvovec
Registration type
NCE/NBE
Indication
LUXTURNA (concentrated solution for injection) is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 mutations and who have sufficient viable retinal cells as determined by the treating physician.
Pathological mutations of RPE65 should be confirmed by a National Association of Testing Authorities (NATA) or International Laboratory Accreditation Cooperation (ILAC) accredited laboratory.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.