Industry NEWS Update - BEQVEZ™

BEQVEZ™​ (fidanacogene elaparvovec-dkzt) Approval Granted by FDA

On April 25, 2024, Pfizer announced that the United States (U.S.) Food and Drug Administration (FDA) approved BEQVEZ™ (fidanacogene elaparvovec-dkzt) injection, for intravenous infusion. 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.

BEQVEZ™ (fidanacogene elaparvovec-dkzt) approved product labeling can be found here: BEQVEZ (fidanacogene elaparvovec-dkzt) U.S. Physician Prescribing Information