U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Cellular & Gene Therapy Products
  4. BEQVEZ
  1. Cellular & Gene Therapy Products

STN: 125786
Proper Name: Fidanacogene elaparvovec-dzkt
Tradename: BEQVEZ
Manufacturer: Pfizer, Inc.
Indication:
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.

Product Information

  • Package Insert - BEQVEZ
  • Demographic Subgroup Information - Fidanacogene elaparvovec-dzkt (BEQVEZ)
    Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

 

 
Back to Top