Benzinga | Nov 22, 2021 06:31AM EST

bluebird bio Announces FDA Priority Review Of Biologics License Application For Beti-Cel Gene Therapy For Patients With -thalassemia Who Require Regular Red Blood Cell Transfusions

If approved, beti-cel will be the first one-time treatment option to address the underlying genetic cause of disease

Current 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 mortality

FDA set PDUFA date of May 20, 2022