Fasenra(benralizumab)
Fasenra (benralizumab) is an antibody pharmaceutical. Benralizumab was first approved as Fasenra on 2017-11-14. It is used to treat asthma in the USA. It has been approved in Europe to treat asthma. It is known to target interleukin-5 receptor subunit alpha.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Fasenra
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)
Benralizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Fasenra | benralizumab | AstraZeneca | N-761070 RX | 2017-11-14 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fasenra | Biologic Licensing Application | 2024-09-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0517 | Injection, benralizumab, 1 mg |
Clinical
Clinical Trials
109 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 3 | 6 | 19 | 10 | 37 | 75 |
| Pulmonary eosinophilia | D011657 | EFO_0007257 | J82.81 | — | — | 4 | 5 | 16 | 25 |
| Eosinophilia | D004802 | HP_0001880 | D72.1 | — | 4 | 5 | 3 | 6 | 16 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | — | 1 | — | 2 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | — | 1 | — | 2 |
| Airway remodeling | D056151 | — | — | — | — | — | 1 | 1 | 2 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | — | — | 1 | — | 1 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | — | — | 1 | — | 1 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nasal polyps | D009298 | HP_0100582 | J33 | — | 1 | 3 | — | 3 | 7 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 3 | 3 | — | — | 7 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 2 | 3 | — | 1 | 7 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | 2 | 3 | — | — | 6 |
| Rhinosinusitis | D000096825 | — | — | — | 2 | 1 | — | 2 | 5 |
| Polyps | D011127 | EFO_0000662 | — | — | — | 1 | — | 3 | 4 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 1 | 3 | — | — | 3 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | — | 2 | 2 | — | — | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 2 | — | 1 | 3 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 2 | — | — | — | 2 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | 2 | — | — | — | 2 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 1 | 2 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 2 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | 1 | — | — | — | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 1 | — | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
| Genetic skin diseases | D012873 | — | — | — | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Benralizumab |
| INN | benralizumab |
| Description | Benralizumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1742991 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12023 |
| UNII ID | 71492GE1FX (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
IL5RA
IL5RA
Organism
Homo sapiens
Gene name
IL5RA
Gene synonyms
IL5R
NCBI Gene ID
Protein name
interleukin-5 receptor subunit alpha
Protein synonyms
CD125, CD125 antigen, CDw125, IL-5 receptor subunit alpha, IL-5R subunit alpha, interleukin 5 receptor type 3, interleukin 5 receptor, alpha, interleukin-5 receptor alpha chain
Uniprot ID
Mouse ortholog
Il5ra (16192)
interleukin-5 receptor subunit alpha (P21183)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Fasenra – AstraZeneca
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,783 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,384 adverse events reported
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