Published 10 days ago

FDA approves Pfizer’s first gene therapy for rare inherited bleeding disorder

Pfizer's gene therapy for a rare genetic bleeding disorder has received FDA approval, marking its first gene therapy clearance in the U.S.
The treatment, named Beqvez, is priced at $3.5 million before insurance and rebates, positioning it as one of the most expensive drugs in the U.S.
Beqvez, a one-time treatment, aims to help patients produce factor IX independently to manage bleeding in hemophilia B.

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Reuters

US FDA approves Pfizer's gene therapy for rare bleeding disorder

10 days ago·United Kingdom

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CNBC

FDA approves Pfizer’s first gene therapy for rare inherited bleeding disorder

The Food and Drug Administration on Friday approved Pfizer’s treatment for a rare genetic bleeding disorder, making it the company’s first-ever gene therapy to win clearance in the U.S.

10 days ago·United States

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Benzinga

FDA Green Lights Pfizer's Gene Therapy For Rare Bleeding Disorder Hemophilia - Pfizer (NYSE:PFE)

Friday, the FDA approved Pfizer Inc’s (NYSE:PFE) Beqvez (fidanacogene elaparvovec-dzkt) for moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var capsid. Beqvez is a one-time treatment designed to en…

10 days ago·New York, United States

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Raw Story

U.S. approves gene therapy treatment for hemophilia

Pharmaceutical giant Pfizer has received U.S. approval for a gene therapy against a form of hemophilia, a rare and inherited blood clotting disorder, the company said Friday.Beqvez, which is given as a single intravenous infusion, was shown in a clinical trial of 45 people to be better at preventing bleeding among adults with moderate to severe hemophilia B, compared to regular infusions of a protein that promotes clotting, called protein factor…

10 days ago·United States

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Medical Xpress

US approves gene therapy treatment for hemophilia

Pharmaceutical giant Pfizer has received US approval for a gene therapy against a form of hemophilia, a rare and inherited blood clotting disorder, the company said Friday.

10 days ago

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