Days after presenting incremental data for its gene therapy lovotibeglogene autotemcel (lovo-cel) for sickle cell disease (SCD), bluebird bio has found itself hit with another potential safety problem, in the form of a partial hold from the US Food and Drug Administration due to an adolescent patient experiencing anemia. That, in turn, has created uncertainty about the company’s filing plans for the therapy.
The company said 20 December that the FDA had placed the partial hold for patients younger than 18, after an...
