Pfizer
A sustained increase in neutralizing anti-AAVRh74var antibodies has been observed after administration of BEQVEZ in all patients who participated in clinical studies and had …
Sep 30, 2025 · The administration of BEQVEZ has the potential to generate immunity in the form of neutralizing antibodies against the vector capsid, the transgene (virus-derived FIX) and as a …
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 …
BEQVEZ™ (fidanacogene elaparvovec-dzkt) Indications and Usage …
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 …
Jul 2, 2024 · Exogenous Factor IX or other hemostatic products may also be required in case of surgery, invasive procedures, trauma, or bleeds in the event that fidanacogene elaparvovec …
Neutralizing antibody testing: CDEC discussed that anti-AAVRh74var neutralizing antibody (nAb) testing would be required to determine eligibility for fidanacogene elaparvovec.
Selection of patients for treatment will be selected based on an FDA-approved companion diagnostic test for neutralizing antibodies (nAbs) to the viral capsid.
BEQVEZ Solution for infusion Pharmacology - MPI, US: SPL/PLR
The administration of BEQVEZ has the potential to generate immunity in the form of neutralizing antibodies against the vector capsid, the transgene (virus-derived factor IX) and as a cellular …
Coverage will be provided for one dose per lifetime. The recommended dose of Beqvez is a one-time (per lifetime) single dose of 5 x 1011 vector genomes per kg of body weight by …
Exogenous Factor IX or other hemostatic products may also be required in case of surgery, invasive procedures, trauma, or bleeds in the event that fidanacogene elaparvovec-derived …