Bluebird bio’s filing of a marketing authorization application (MAA) with the European Medicines Agency for its LentiGlobin gene therapy for the treatment of patients with transfusion-dependent β-thalassemia (TDT) brings to five the number of products being reviewed under the agency’s accelerated assessment mechanism.
The US company announced on Oct. 5 that the EMA had accepted its MAA for LentiGlobin in this indication under...