SPX3,825.33+39.95 1.06%
DIA310.85+3.03 0.98%
IXIC11,127.85+99.11 0.90%

bluebird bio Announces FDA Advisory Committee Unanimously Supports beti-cel Gene Therapy For People With beta-thalassemia Who Require Regular Red Blood Cell Transfusions

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 If approved, beti-cel will

Benzinga · 06/10/2022 16:33

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

If approved, beti-cel will be the first potentially curative gene therapy option for people with beta-thalassemia who require regular red blood cell transfusions and the first ex-vivo LVV gene therapy available in the U.S.

PDUFA goal date is set for August 19, 2022