25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median annualised bleed rate of zero bleeds (range 0 to 9.9) after up to four years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients.
Pfizer today announced that the European Commission has granted conditional marketing authorisation for Durveqtix (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe haemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74.