FDA to decide on bluebird's lovo-cel without AdCom meeting

The US Food and Drug Administration (FDA) has told bluebird bio (Nasdaq: BLUE) that an advisory committee (AdCom) meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel).

This move could be seen as removing a potential obstacle to gaining approval for lovo-cel, a one-time gene therapy for sickle cell disease (SCD) with a proposed indication for patients aged 12 and older who have a history of vaso-occlusive events.

"Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease"The FDA 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 this year.