FDA Panel Votes Unanimously in Favor of Gene Therapy to Treat Rare Eye Disorder
By Zachary Brennan -
Published 12 October 2017
Philadelphia-based Spark Therapeutics took its gene therapy before the US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee on Thursday and the panel voted 16 to 0 in favor of approving the subretinal injection, representing a major step forward for adeno-associated virus gene therapies.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: Spark Therapeutics, gene therapy, retinal disease, Luxturna