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# FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study
- URL: https://www.fdaweb.com/fda-lifts-partial-hold-on-bluebird-bio-lovo-cel-study/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153425

FDA has lifted its partial clinical hold for patients under age 18 in studies evaluating Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) for sickle cell disease. A company [statement](https://investor.bluebirdbio.com/news-releases/news-release-details/fda-lifts-partial-clinical-hold-bluebird-bios-sickle-cell?ref=fdaweb.com) says the agency placed the studies on a partial hold for patients under age 18 in 12/2021 relating to a company investigation into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel.

Bluebird says its study of two patients with persistent anemia determined that they had two *a*\-globin gene deletions, known as alpha-thalassemia trait, and the genotype was added to exclusion criteria for ongoing studies.

The company says it is working to resume enrollment and treatment of patients aged 2-17 consistent with the study protocol and remains on track to submit a BLA in the first quarter of this year.

FDA has granted orphan drug, fast track, regenerative medicine advanced therapy, and rare pediatric disease designations for lovo-cel, Bluebird says.

Lovo-cel gene therapy is described as an investigational one-time treatment being studied for sickle cell disease that is designed to add functional copies of a modified form of the β-globin gene into a patient’s hematopoietic stem cells.