Bluebird Bio To Resume Zynteglo Gene Therapy Marketing In Europe After Positive Recommendation From PRAC

European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefit-risk of Bluebird Bio Inc's BLUE Zynteglo (betibeglogene autotemcel gene therapy) remains favorable.
Hence EMA is lifting the voluntary marketing suspension on Zynteglo indicated for patients with transfusion-dependent β-thalassemia.
Since Zynteglo is manufactured using the same BB305 lentiviral vector used in bb1111 in sickle cell disease, bluebird bio temporarily suspended the marketing of the product. At the same time, the root cause of the myelodysplastic syndrome reported earlier was investigated by the company and assessed by the PRAC.
Last month, the FDA lifted the clinical hold on LentiGlobin gene therapy trials in sickle cell disease and transfusion-dependent β-thalassemia.
No cases of hematologic malignancy have been reported in any patient who has received treatment with Zynteglo, the company said.
Price Action: BLUE shares are up 1.56% at $30.91 during the market session on the last check Friday.