Bluebird Bio: No FDA Advisory Committee Meeting Scheduled For Lovo-cel Gene Therapy

(RTTNews) - bluebird bio, Inc. (BLUE) announced the FDA has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel. Lovo-cel is a one-time gene therapy for individuals living with sickle cell disease with a proposed indication for patients ages 12 and older who have a history of vaso-occlusive events.

Andrew Obenshain, chief executive officer, bluebird bio, said: "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 accepted the lovo-cel Biologics Licensing Application for Priority Review and set a Prescription Drug User Fee Act goal date of December 20, 2023.