Betaseron, Betaferon(interferon beta-1b)
Betaferon, Betaseron, Extavia (interferon beta-1b) is a protein pharmaceutical. Interferon beta-1b was first approved as Betaseron on 1993-07-23. It is used to treat multiple sclerosis in the USA. It has been approved in Europe to treat multiple sclerosis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Betaseron (discontinued: Extavia)
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| betaseron | Biologic Licensing Application | 2023-07-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1830 | Injection, interferon beta-1b, 0.25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) |
Clinical
Clinical Trials
99 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 5 | 6 | 5 | 37 | 52 |
| Sclerosis | D012598 | — | — | — | 4 | 6 | 4 | 33 | 46 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 4 | 2 | 4 | 10 | 20 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | 1 | — | 2 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | — | R53.83 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Atrophy | D001284 | — | — | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Interferon beta-1b |
| INN | — |
| Description | Interferon beta precursor (IFN-beta) (Fibroblast interferon) |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201563 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00068 |
| UNII ID | — |
Target
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Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,111 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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31,973 adverse events reported
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