(fidanacogene elaparvovec-dzkt)

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Indications and Usage

1 INDICATIONS AND USAGE

BEQVEZ is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who:

Currently use factor IX prophylaxis therapy, or
Have current or historical life-threatening hemorrhage, or
Have repeated, serious spontaneous bleeding episodes, and,
Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.

Select patients for therapy based on an FDA-approved companion diagnostic for BEQVEZ [see Dosage and Administration (2)].

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