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Health Canada Grants Approval to Pfizer’s Beqvez for Hemophilia B Gene Therapy

NextEdge Admin

05 Dec 2023

2 min 8 sec

Pfizer’s gene therapy treatment, Beqvez (fidanacogene elaparvovec), has received approval from Health Canada for the management of hemophilia B, a rare genetic bleeding disorder. The approval allows Beqvez to be utilized in adults with moderately severe to severe hemophilia B who are negative for neutralizing antibodies to variant adeno-associated viral (AAV) serotype Rh74. This gene therapy involves a one-time administration using an AAV vector to deliver a variant of the FIX gene, addressing the deficiency in the blood clotting protein FIX.

Patients treated with Beqvez are anticipated to produce FIX independently, eliminating the need for regular intravenous infusions of plasma-derived or recombinant FIX, which is the current standard care for hemophilia B. Health Canada’s approval is based on data from Pfizer’s Phase III study, BENEGENE-2, which included 45 adult male patients. The study compared the annualized bleeding rate in those treated with Beqvez to those receiving standard FIX prophylaxis replacement. Results indicated a lower mean annualized bleeding rate (1.3) with Beqvez compared to intravenous FIX infusions (4.43) during the lead-in pretreatment period.

Beqvez’s approval marks the second gene therapy for hemophilia B in Canada, following CSL Behring’s Hemgenix (etranacogene dezaparvovec), approved in October. While Beqvez has gained approval in Canada, it is currently undergoing regulatory review in the United States and the European Union.