bluebird's LentiGlobin gets EMA's PRIME designation

bluebird Bio Inc. (NASDAQ:BLUE) said EMA accepted gene therapy candidate LentiGlobin BB305 into its PRIority MEdicines (PRIME) scheme as a treatment for transfusion-dependent beta-thalassemia. The pathway was launched in March to speed assessment of therapies that may benefit patients with no treatment options, or may offer a major therapeutic advantage over existing therapies (see BioCentury, March 21).

Earlier this month, bluebird began a Phase III study of LentiGlobin to treat beta-thalassemia. The therapycomprises autologous CD34+ stem cells transduced ex vivo with a lentiviral vector delivering the human beta globin gene (see BioCentury Extra, Sept. 8). ...