lovotibeglogene autotemcel
Trade name: Lyfgenia
Gene therapyapprovedOrphan Drug FDA
Approved
Dec 8, 2023
Clinical trial activity
0 trials · 0 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Timeline
2010s
- Feb 26, 2014
Orphan Drug Designation
2020s
- Dec 8, 2023
bluebird bio — Earliest FDA Approval
- Dec 8, 2023
bluebird bio — NDA Organization
Indications
Approved for
Mechanism of action
- Hemoglobin beta chainEXOGENOUS GENE
Hemoglobin beta chain exogenous gene
Autologous genome edited cell therapy
- Hemoglobin beta chainSupplementation
HBB supplementation
Approval history
- approvedDec 8, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4650269 ↗
Organizations
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| bluebird bio | For profit | NDA | Dec 8, 2023 |