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

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.

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