Pfizer’s bags EC approval for hemophilia B drug Durveqtix

The European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), from US pharma giant Pfizer (NYSE: PFE).

The gene therapy is authorized for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. Durveqtix is designed to enable people living with hemophilia B to produce factor IX (FIX) themselves via a one-time dose, rather than multiple intravenous FIX infusions weekly or biweekly with the current standard of care.

The EC approval follows recent regulatory approvals by the US Food and Drug Administration (FDA) and Health Canada, where it is marketed as Beqvez.