bluebird bio Announces FDA Priority Review of Biologics License Application for beti-cel Gene Therapy for Patients with ß-thalassemia Who Require Regular Red Blood Cell Transfusions
bluebird bio, Inc. (BLUE)
Last bluebird bio, inc. earnings: 2/18 04:05 pm
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Source: Business Wire
If approved, beti-cel will be the first one-time treatment option to address the underlying genetic cause of diseaseCurrent standard of care relies on regular red blood cell transfusions and iron management that carry the risk of progressive multi-organ damage and increased risk of morbidity and mortalityFDA set PDUFA date of May 20, 2022 CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for betibeglogene autotemcel (beti-cel) for priority review. Beti-cel is a potentially transformative gene therapy for adult, adolescent and pediatric patients with ß-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions. If approved, beti-cel will be the first one-time treatment that addresses the underlying genetic cause of disease for patients living with ß-thalassemia in the U.S.—offering an alternative to regular RBC transfusi
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