FDA Lifts Partial Clinical Hold On Bluebird Bio's Sickle Cell Disease Studies

(RTTNews) - bluebird bio, Inc. (BLUE) on Monday said the U.S. Food and Drug Administration lifted its partial clinical hold on the company's studies evaluating lovotibeglogene autotemcel (lovo-cel) for the treatment of patients below 18 years with sickle cell disease (SCD).

lovo-cel gene therapy is an investigational one-time treatment for sickle cell disease.

In December 2021, lovo-cel studies were placed on a partial hold for patients under the age of 18 following non-transfusion-dependent anemia after treatment with lovo-cel in an adolescent patient.

bluebird said it is on track to submit a Biologics License Application (BLA) to the FDA for lovo-cel in the first quarter of 2023.