ex-vivo gene therapy
data set in the world.
our research
bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world-setting, having secured FDA approvals for three therapies over the course of two years. These approvals are the culmination of more than a decade of clinical research across 8 studies. bluebird’s depth and breadth of gene therapy expertise is unmatched – more than 200 patients have been treated with LVV gene therapies through our clinical programs, representing more than 1,000 patient years of experience. But our dedication to clinical research doesn’t end there.
bluebird’s research includes both long-term follow-up studies that will monitor patients who participated in Phase 1, Phase 2, and Phase 3 clinical studies of bluebird therapies for an additional 13 years for a total of 15 years of follow-up, as well as 15-year post-marketing long-term follow-up studies.
- Phase 1
- Phase 2
- Phase 3
- Long-Term Follow Up
- Phase 4
-
lovotibeglogene autotemcel gene therapy (lovo-cel)
FDA APPROVED 12/8/2023 -
-
-
-
β-THALASSEMIA
-
betibeglogene autotemcel gene therapy (beti-cel)
FDA APPROVED 8/17/2022 -
-
-
-
-
ADRENOLEUKODYSTROPHY
-
elivaldogene autotemcel (eli-cel)
FDA APPROVED 9/16/2022 -
-
-
* Ongoing studies
** Planned Study