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Novartis/Spark’s sight gene therapy approved in EU

November 23, 2018 / Richard Staines

Spark Therapeutics’ gene therapy for a rare inherited sight disorder, Luxturna has been approved in Europe, but there was still no word on price from marketing partner Novartis. The European Commission granted a marketing authorization for Luxturna as a one-time gene therapy for adult and paediatric patients with vision loss due to inherited dystrophy caused by confirmed biallelic RPE65 mutations. Patients must also have sufficient viable retinal cells to be eligible. Novartis will market Luxturna outside of the US, after buying the rights to Luxturna (voretigene neparvovec) in a deal signed in January. The Swiss pharma is being cagey about its pricing plans for the one-off therapy – but in the US where Luxturna was approved late last year, Spark charges $850,000 for a single round of treatment at full price. However, Novartis said a few weeks ago, after regulators on Europe’s Committee for Medicinal Products for Human Use (CHMP) gave Luxturna the green light, that it...