Orchard's gene therapy a step closer to US approval
Gene therapy company Orchard Therapeutics (Nasdaq: ORTX) has announced that the US 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 FDA has set a Prescription Drug User Fee Act goal date of March 18, 2024. If approved, OTL-200 would be the first and only treatment in the USA for early-onset MLD.
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