BLUE - bluebird bio to resume Zynteglo marketing in EU for ?-thalassemia

The EMA's Pharmacovigilance Risk Assessment Committee confirms favorable benefit-risk balance of bluebird bio's (BLUE) Zynteglo for transfusion-dependent ?-thalassemia patients.BLUE shares up 2% premarket at $30.97.The company has informed the EMA that it is lifting the voluntary marketing suspension.As a next step, the recommendation will be forwarded to the Committee for Advanced Therapies and Committee for Medicinal Products for Human Use for adoption. No cases of hematologic malignancy have been reported in patients receiving Zynteglo. However because it is manufactured using the same BB305 lentiviral vector used in LentiGlobin for sickle cell disease, bluebird bio decided to temporarily suspend marketing of Zynteglo while the root cause of the safety events reported for LentiGlobin for SCD were investigated.Earlier last month, the FDA had lifted clinical holds on trials for LentiGlobin and Zynteglo in ?-Thalassemia.

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bluebird bio to resume Zynteglo marketing in EU for ?-thalassemia