FDA has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel for treatment of sickle cell disease
bluebird bio, Inc. announced that the 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, 2023.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.