On October 12, 2017, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) unanimously supported, by a vote of 16-Yes to 0-No, with no abstentions, the safety and efficacy of voretigene neparvovec by Spark Therapeutics, Inc. (Spark). The proposed indication is the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. The proposed trade name is Luxturna. The FDA’s goal date for a decision (PDUFA date) is January 12, 2018.
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Earlier Event: October 4Vaccines and Related Biological Products Advisory Committee
Later Event: October 13Dermatologic and Ophthalmic Drugs Advisory Committee