Posted by Michael Wonder on 13 Aug 2020
TGA approves new gene therapy from Novartis
13 August 2020 - Luxturna has been for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 mutations.
Luxturna (voretigene neparvovec) 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 or International Laboratory Accreditation Cooperation accredited laboratory.
Luxturna is to be included in the Black Triangle Scheme.
Next step is reimbursement. An application to the Medicare Services Advisory Committee for Luxturna has already been made.
