Active Ingredient: Eladocagene exuparvovec
Eladocagene exuparvovec is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L-amino acid decarboxylase (AADC) deficiency with a severe phenotype.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intracerebral, 0.08 milliliters eladocagene exuparvovec, 4 doses in total.
Patients will receive a total dose of 1.8 × 1011 vg delivered as four 0.08 mL (0.45 × 1011 vg) infusions (two per putamen).
The posology is the same for the entire population covered by the indication.
Intraputaminal use.
Four separate infusions of equal volumes are performed to the right anterior putamen, right posterior putamen, left anterior putamen, and left posterior putamen.
The target infusion sites are defined per standard stereotactic neurosurgical practice. Eladocagene exuparvovec is administered as a bilateral infusion (2 infusions per putamen) with an intracranial cannula. The final 4 targets for each trajectory should be defined as 2 mm dorsal to (above) the anterior and posterior target points in the mid-horizonal plane.
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