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The therapy is currently approved in the EU as a gene therapy for the treatment of patients 12 years and older with transfusion-dependent β-thalassemia.
apceth Biopharma, a subsidiary of Hitachi Chemical, announced on Jan. 13, 2019 it would begin the commercial manufacturing of Zynteglo, a product of bluebird bio.
According to an apceth press release, Zynteglo is currently approved in the EU as a gene therapy for the treatment of patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen-matched related HSC donor is not available.
“Manufacturing this life-changing therapy for TDT patients in Europe marks a milestone for our company and the global Regenerative Medicine Business Sector at Hitachi Chemical Co., Ltd.”, said Dr. Christine Guenther, CEO of apceth Biopharma, in the press release. “I am very proud of the teams of apceth and bluebird bio working together to make this happen. Our trustful partnership and persistent efforts over many years have made this vision come true for the patients.”
“We appreciate the team at apceth for all of their hard work and commitment to patients living with TDT,” added Nick Leschly, chief bluebird, in the press release. “This is a critical step along our journey as we advance our launch and access activities in Europe. We look forward to continuing our work with our partners, the TDT community and health systems to bring Zynteglo to patients.”