The US Food and Drug Administration’s approval of Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt) for hemophilia B provides an early example of the nascent competitive landscape between gene therapies, particularly as manufacturers have previously mostly pursued niche indications in which they did not compete with one another.
Pfizer announced the FDA approval of Beqvez on 26 April for adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, who have current or prior life-threatening hemorrhage or have repeated, serious bleeding episodes and who do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid,
Key Takeaways
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The FDA approved Pfizer’s gene therapy Beqvez for hemophilia B, putting it in competition with uniQure/CSL’s Hemgenix.
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The list price for Beqvez is $3.5m, the same as Hemgenix, and Pfizer is planning a warranty-based reimbursement program based on durability of response
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