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Orchard Therapeutics Says FDA Accepts BLA For OTL-200 In Metachromatic Leukodystrophy

Por: RTTNews Health September 18, 2023

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Orchard Therapeutics (), a global gene therapy leader, announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review.The BLA for OTL-200 is based on data from 39 pediatric patients with early-onset MLD, enrolled in two prospective non-randomized clinical studies or treated under expanded access... + full article



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