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
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 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fasenra | Biologic Licensing Application | 2021-02-23 |
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
70 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 | 18 | 6 | 3 | 36 |
| Eosinophilia | D004802 | HP_0001880 | D72.1 | — | 2 | 1 | 3 | 1 | 7 |
| Chronic urticaria | D000080223 | L50.8 | — | 1 | — | 1 | — | 2 | |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 3 | 3 | — | — | 7 |
| Nasal polyps | D009298 | HP_0100582 | J33 | — | 1 | 1 | — | 2 | 4 |
| Gastroenteritis | D005759 | EFO_1001463 | K52.9 | — | 1 | 2 | — | — | 2 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | — | 1 | — | — | 1 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | — | 1 | — | — | 1 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | — | — | 1 | — | — | 1 |
| Churg-strauss syndrome | D015267 | EFO_0007208 | M30.1 | — | — | 1 | — | — | 1 |
| Exercise-induced asthma | D001250 | J45.990 | — | — | 1 | — | — | 1 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | 1 | — | — | 1 |
| Leukocyte disorders | D007960 | D72.9 | — | 1 | 1 | — | — | 1 |
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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 |
| Hematologic neoplasms | D019337 | — | 1 | — | — | — | 1 | ||
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Eczema | D004485 | HP_0000964 | L30.9 | — | 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 | |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 1 | — | — | — | 1 |
| Genetic skin diseases | D012873 | — | 1 | — | — | — | 1 | ||
| Eczematous skin diseases | D017443 | — | 1 | — | — | — | 1 |
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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
No data
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 | 1044511-01-4 |
| RxCUI | 1989100 |
| 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
Clinical Variant
No data
Financial
Fasenra - AstraZeneca
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€
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,000 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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409 adverse events reported
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