https://seekingalpha.com/news/3531175-bluebird-bio-launches-zynteglo-for-tdt-in-germanyous CD34+ cells encoding βA-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell transplantation is appropriate but a human leukocyte antigen-matched related HSC donor is not available. This is the first time ZYNTEGLO is commercially available.
Bluebird has also collaborated with University Hospital of Heidelberg as the first qualified treatment center in Germany.
In addition, bluebird has entered into value-based payment agreements with multiple statutory health insurances in Germany to help ensure patients and their healthcare providers have access to ZYNTEGLO.
Bluebird has initiated the rolling BLA submission for U.S. FDA approval. The company is planning to complete the BLA submission in H1 2020.
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