US FDA Approves Pfizer's BEQVEZ™, a One-Time Gene Remedy for Adults with Hemophilia B – The Journal of Healthcare Contracting

US FDA Approves Pfizer's BEQVEZ™, a One-Time Gene Remedy for Adults with Hemophilia B – The Journal of Healthcare Contracting



April 30, 2024 – Pfizer Inc. introduced that the U.S. Meals and Drug Administration (FDA) has authorized BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the remedy of adults with reasonable to extreme hemophilia B who’re presently taking issue IX (FIX) prophylaxis remedy or have a present or historical past of life-threatening bleeding has, or has recurrent, extreme spontaneous bleeding, and doesn’t have neutralizing antibodies to the adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved check.

Hemophilia B is a uncommon genetic bleeding dysfunction that forestalls regular blood clotting as a consequence of a deficiency of FIX, inflicting individuals with the illness to bleed extra usually and for longer than others.

BEQVEZ is a one-time remedy designed to permit individuals with hemophilia B to supply FIX on their very own as a substitute of the present normal of care, which requires common intravenous infusions of FIX usually given a number of occasions per week or a number of occasions a month.

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