1. Pink Sheet

EU Hat Trick For Bluebird’s Beta-Thalassemia Gene Therapy

 
• By Neena Brizmohun

bluebird bio is set to enter the EU market with the first gene therapy for transfusion-dependent β-thalassemia, after the European Medicines Agency reviewed its product in record time. Bluebird believes that the agency’s Priority Medicines (PRIME) and adaptive pathways programs have been instrumental in smoothing its path.

Record time
The CHMP reviewed Zynteglo in record time. • Source: Shutterstock

bluebird bio has scored a series of firsts with its life-changing beta-thalassemia gene therapy, Zynteglo, after the European Medicines Agency today recommended that the product should be marketed in the EU.

Zynteglo, formerly referred to as LentiGlobin, is the first gene therapy recommended for approval in the EU for transfusion-dependent β-thalassemia (TDT)

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