BioCentury
ARTICLE | Clinical News

bluebird on track to submit MAA to EMA for LentiGlobin

June 22, 2018 6:26 PM UTC

bluebird bio Inc. (NASDAQ:BLUE) said it is on track to submit an MAA to EMA next half for its LentiGlobin BB305 to treat beta-thalassemia and reported additional data from three studies of the gene therapy. LentiGlobin BB305 comprises autologous CD34+ stem cells transduced ex vivo with a lentiviral vector delivering the human beta globin gene.

The company reported data from the open-label, international Phase III Northstar-2 (HGB-207) and the open-label, international Phase I/II Northstar (HGB-204) studies to treat transfusion-dependent beta-thalassemia patients with non-beta-0/beta-0 genotypes...