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Luxturna FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved December 19, 2017)
Brand name: Luxturna
Generic name: voretigene neparvovec
Dosage form: Intraocular Suspension for Subretinal Injection
Company: Spark Therapeutics, Inc.
Treatment for: Biallelic RPE65-Mediated Inherited Retinal Disease

Luxturna (voretigene neparvovec) is an adeno-associated viral (AAV) vector gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).

Development Timeline for Luxturna

DateArticle
Dec 19, 2017Approval  FDA Approves Luxturna (voretigene neparvovec-rzyl) Gene Therapy to Treat Patients with a Rare Form of Inherited Vision Loss
Nov 10, 2017Three-year Follow-up Phase 3 Data Provide Additional Information on Efficacy, Durability and Safety of Investigational Luxturna (voretigene neparvovec) in Patients with Biallelic RPE65-mediated Inherited Retinal Disease
Oct 19, 2017FDA Advisory Committee Unanimously Recommends Approval of Investigational Luxturna (voretigene neparvovec) for Patients with Biallelic RPE65-mediated Inherited Retinal Disease

Further information

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