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Bluebird Bio's Zynteglo Receives CHMP's Positive Opinion for Conditional Marketing for Patients with Transfusion-Dependent β-Thalassemia (TDT) without β0/β0 Genotype

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Bluebird Bio's Zynteglo Receives CHMP's Positive Opinion for Conditional Marketing for Patients with Transfusion-Dependent β-Thalassemia (TDT) without β0/β0 Genotype

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  • The positive opinion is based on P-I/II HGB-205 & Northstar (HGB-204) and P-III Northstar-2 (HGB-207) & Northstar-3 (HGB-212) studies assessing Zynteglo in patients with transfusion-dependent β-thalassemia (TDT) who do not have β0/β0 genotype aged 12 yrs. and older
  • Collective data from studies: 80% achieved transfusion independence with median duration of 38 mos.; @6mos. median (min – max) total hemoglobin for patients was 11.9 g/dL
  • Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) is a gene therapy- formerly known as LentiGlobin targeted for TDT and reviewed under EMA’s PRIME and Adaptive Pathways programs with its expected European Commission approval in Q2’19

  Ref: Bluebird Bio | Image: Twitter

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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