약학회지

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Table. 3.

Table. 3. Approval records of AAV vector gene therapy drugs using expedited programs of FDA and EMA
Agency Program Luxturna Zolgensma Hemgenix
FDA Orphan Drug Y* Y Y
Fast Track N Y N
Breakthrough Therapy Y* Y Y
Priority Review Y Y Y
Accelerated Approval N N N
EMA Orphan Drug Y Y Y
Centralized Procedure Y Y Y
PRIME N Y Y
Accelerated Assessment N Y N
Conditional Approval N Y Y

N/A: non-applicable, Y: approved, N: not associated.

*RPD Rare Pediatric Disease

Yakhak Hoeji 2023;67:342-53 https://doi.org/10.17480/psk.2023.67.6.342
© 2023 Yakhak Hoeji