Lovotibeglogene autotemcel
Lyfgenia (lovotibeglogene autotemcel) is a gene pharmaceutical. Lovotibeglogene autotemcel was first approved as Lyfgenia on 2023-12-08.
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Lyfgenia
Drug Products
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Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Lovotibeglogene autotemcel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| LYFGENIA | lovotibeglogene autotemcel | bluebird bio | N-125788 RX | 2023-12-08 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lyfgenia | Biologic Licensing Application | 2024-08-29 |
Indications
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Agency Specific
FDA
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Expiration | Code | ||
|---|---|---|---|
lovotibeglogene autotemcel, LYFGENIA, bluebird bio Inc. | |||
| 2030-12-08 | Orphan excl. | ||
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Clinical
Clinical Trials
2 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 1 | 1 | — | — | 2 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lovotibeglogene autotemcel |
| INN | lovotibeglogene autotemcel |
| Description | Lovotibeglogene autotemcel, sold under the brand name Lyfgenia, is a lentiviral gene therapy used for the treatment of sickle cell disease.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650269 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB18680 |
| UNII ID | 2C6A9NH2Z8 (ChemIDplus, GSRS) |
Target
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Lyfgenia – bluebird bio
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Safety
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Adverse Events
0 adverse events reported
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