October 12, 2017
On October 12, 2017, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Biologics License Application (BLA) 125610, voretigene neparvovec, submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
- Briefing Document Errata
- Briefing Document BLA 125610 (Voretigene Neparvovec)
- Briefing Document LUXTURNA (Voretigene Neparvovec)
Sparks Therapeutics, Inc.
- Draft Agenda
- Draft Questions for the Advisory Committee
- Draft Roster
- Final Agenda
- Final Questions for the Advisory Committee
- Final Roster
- Summary Minutes
- Waivers for Conflicts of Interest