Bluebird Bio: FDA advisory committee not scheduling meeting for lovo-cel

bluebird bio announced that the U.S. Food and Drug Administration FDA has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel lovo-cel . Lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease SCD with a proposed indication for patients ages 12 and older who have a history of vaso-occlusive events VOEs . The Agency previously accepted the lovo-cel Biologics Licensing Application BLA for Priority Review and set a Prescription Drug User Fee Act PDUFA goal date of December 20. “Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease and represents the third lentiviral vector gene therapy that the Agency has reviewed from bluebird-giving us great confidence in the robustness and maturity of our BLA package,” said Andrew Obenshain, chief executive officer, bluebird bio. “We remain focused on working with the Agency on its review in anticipation of a decision by the end of this year.”..The FDA previously granted lovo-cel orphan drug designation, fast track designation, regenerative medicine advanced therapy RMAT designation, and rare pediatric disease designation.