An FDA advisory committee voted unanimously that Spark Therapeutics’ Luxturna gene therapy for retinal dystrophy has an overall favorable benefit-risk profile.
Sixteen members of the Cellular, Tissue, and Gene Therapies Advisory Committee voted yes and zero voted no, with zero abstentions, on the following question: Considering the efficacy and safety information provided in the briefing document, as well as the presentations and discussions during the AC meeting, does voretigene neparvovec have an overall favorable benefit-risk profile for the treatment of patients with vision loss due
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