Exagamglogene autotemcel
Casgevy (exagamglogene autotemcel) is a gene pharmaceutical. Exagamglogene autotemcel was first approved as Casgevy on 2023-12-08. It is used to treat sickle cell anemia in the USA.
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Commercial
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Casgevy
Drug Products
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Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
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Biosimilar product - 351(k)
Biosimilar product - 351(k)
Exagamglogene autotemcel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Casgevy | Exagamglogene autotemcel | Vertex Pharmaceuticals | N-125787 RX | 2023-12-08 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| casgevy | Biologic Licensing Application | 2024-09-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| sickle cell anemia | EFO_0000697 | D000755 | D57 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
exagamglogene autotemcel, Casgevy, Vertex Pharmaceuticals Inc | |||
| 2031-01-16 | Orphan excl. | ||
Patent Expiration
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Clinical
Clinical Trials
7 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 2 | 6 | — | — | 6 |
| Hemoglobinopathies | D006453 | — | D58.2 | — | 2 | 6 | — | — | 6 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | 5 | — | — | 5 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 1 | 4 | — | — | 4 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | 1 | 4 | — | — | 4 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | 1 | 4 | — | — | 4 |
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 | Exagamglogene autotemcel |
| INN | exagamglogene autotemcel |
| Description | Exagamglogene autotemcel, sold under the brand name Casgevy, is a gene therapy used for the treatment of sickle cell disease and transfusion-dependent beta thalassemia. It was developed by Vertex Pharmaceuticals and CRISPR Therapeutics.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL5095474 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15572 |
| UNII ID | S53L777GM8 (ChemIDplus, GSRS) |
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Casgevy – Vertex Pharmaceuticals
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Safety
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No Black-box warning
Adverse Events
0 adverse events reported
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