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.

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