Novartis/Spark’s sight gene therapy approved in EU
Pharmaphorum Media Limited | November 23, 2018
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 would be looking to find novel ways to ensure patients receive the drug. The company at the time said it was “committed to working with payers to develop innovative payment models and patient access programmes that address the unique aspects of a one-time gene therapy.”