EMA Withdrawn: Zynteglo (autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene) — bluebird bio (Netherlands) B.V.

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Summary

EMA withdrawn Zynteglo, a gene therapy for beta-thalassemia previously granted conditional approval.

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Diseases / indications

• Beta-thalassemia

Drugs mentioned

• Zynteglo (luspogene nepogene)

Snippet

Status: Withdrawn. Therapeutic area: beta-Thalassemia. MAH: bluebird bio (Netherlands) B.V.. Decision date: 09/12/2021. Conditional approval. Accelerated assessment