Pegademase bovine
Adagen (pegademase bovine) is an enzyme pharmaceutical. Pegademase bovine was first approved as Adagen on 1990-03-21. It is used to treat severe combined immunodeficiency in the USA.
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Commercial
Therapeutic Areas
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EMA
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Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Pegademase bovine
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Adagen | pegademase bovine | Leadiant Biosciences | N-19818 DISCN | 1990-03-21 | 1 products |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| severe combined immunodeficiency | HP_0004430 | D016511 | D81.6 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
pegademase bovine, Adagen, Leadiant Biosciences, Inc | |||
| 2097-03-21 | Orphan excl. | ||
Patent Expiration
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ATC Codes
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HCPCS
Code | Description |
|---|---|
| J2504 | Injection, pegademase bovine, 25 iu |
Clinical
Clinical Trials
10 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 |
|---|---|---|---|---|---|---|---|---|---|
| Severe combined immunodeficiency | D016511 | HP_0004430 | D81.6 | 4 | 5 | 1 | — | 4 | 10 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 2 | 3 | 1 | — | 2 | 6 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| X-linked combined immunodeficiency diseases | D053632 | EFO_1001451 | — | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pegademase bovine |
| INN | — |
| Description | Adagen (pegademase bovine) is an enzyme pharmaceutical. Pegademase bovine was first approved as Adagen on 1990-03-21. It is used to treat severe combined immunodeficiency in the USA. |
| Classification | Enzyme |
| Drug class | enzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201514 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | — |
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Additional graphs summarizing 220 documents
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Safety
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153 adverse events reported
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