BRIEF—FDA lifts partial clinical hold for bluebird bio's SCD studies

The US Food and Drug Administration (FDA) has lifted its partial clinical hold for patients under the age of 18 in studies evaluating lovotibeglogene autotemcel (lovo-cel) for sickle cell disease (SCD) by US biotech bluebird bio, whose shares were down 8.5% at $6.96 despite the positive development.

In December 2021, lovo-cel clinical studies were placed on a partial hold for patients under the age of 18. The hold related to an investigation by bluebird bio into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel.

Bluebird says it has completed treatment of all patients in HGB-206 Group C, which will form the primary basis for efficacy in its lovo-cel BLA submission and expects to complete vector and drug product analytical comparability studies for the lovo-cel BLA in the fourth quarter of 2022.