Safety Concerns Hit Bluebird Sickle Cell Trial, Again

The FDA placed a partial hold on its clinical program for lovo-cel due to an adolescent patient experiencing anemia 18 months after treatment, raising uncertainty over filing plans.

Sickle cell anemia, 3D illustration showing blood vessel with normal and deformated crescent-like red blood cells — The FDA placed a partial hold on bluebird bio's clinical program for lovo-cel in sickle cell disease • Source: Shutterstock

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...