Health Canada approves Pfizer Canada's gene therapy in haemophilia B

Pfizer

3 January 2024 - Pfizer Canada announced that Health Canada approved Beqvez (fidanacogene elaparvovec), an adeno-associated viral vector-based gene therapy for the treatment of adults (aged 18 years or older) with moderately severe to severe haemophilia B (congenital factor IX deficiency) who are negative for neutralising antibodies to variant AAV serotype Rh74.

Health Canada's approval for Brqvez is based on the open-label, single-arm Phase 3 BENEGENE-2 study, to evaluate the efficacy and safety of fidanacogene elaparvovec in adult male participants (age 18–65) with moderately severe to severe haemophilia B (defined as factor IX circulating activity of 2% or less).

Read Pfizer press release 

Michael Wonder

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Michael Wonder

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Outcome , Canada , Gene therapy