Spark Therapeutics also has its own contracting model, Spark PATH, under which a patient can purchase directly or pay in installments based on the therapy’s outcome. The gene therapy is covered under all the major national payers, making it more accessible. On its third-quarter earnings call, the company stated that Luxturna has done well since its launch in the United States with sales growing every quarter. Spark Therapeutics will manufacture and supply Luxturna to Novartis under a supply agreement. Thus, Novartis will be responsible for launch and distribution of the gene therapy in Europe. Please note that Spark Therapeutics has a licensing and commercialization agreement with Novartis Pharma NVS, which granted the latter rights to develop and commercialize Luxturna outside the United States.
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Data from the phase III trial showed that vision improvement was recorded as early as 30 days following the treatment. Data from a phase I clinical trial, its follow-up trial, and the first randomized, controlled phase III gene therapy trial for an inherited disease supported the decision. The EC decision was based on positive CHMP opinion.
The RPE65 mutations, a progressive disease, can lead to total blindness. The MAA sought approval for the therapy in adult as well as pediatric patients as a one-time treatment for vision loss due to inherited retinal dystrophy caused by a genetic mutation in both copies of the RPE65-gene and who have enough viable retinal cells. ONCE announced that the European Commission (“EC”) has approved the marketing authorization application (“MAA”) for its gene therapy, Luxturna (voretigene neparvovec).
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