U.S. License Holder:

Pfizer, Inc.

Date of License:

April-25-2024

FDA-Approved Indications

BEQVEZ (fidanacogene elaparvovec-dzkt) 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.