Saphnelo(anifrolumab)
Saphnelo (anifrolumab) is an antibody pharmaceutical. Anifrolumab was first approved as Saphnelo on 2021-07-30. It has been approved in Europe to treat systemic lupus erythematosus. The pharmaceutical is active against interferon alpha/beta receptor 1.
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FDA Novel Drug Approvals 2021
Commercial
Trade Name
FDA
EMA
Saphnelo
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)
Anifrolumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Saphnelo | anifrolumab-fnia | AstraZeneca | N-761123 RX | 2021-07-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
saphnelo | Biologic Licensing Application | 2021-07-30 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
C9086 | Injection, anifrolumab-fnia, 1 mg |
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 3 | 4 | 5 | — | 1 | 13 |
Lupus nephritis | D008181 | EFO_0005761 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ANIFROLUMAB |
INN | anifrolumab |
Description | Anifrolumab (human mab) |
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 1326232-46-5 |
RxCUI | — |
ChEMBL ID | CHEMBL2364653 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB78910 |
UNII ID | 38RL9AE51Q (ChemIDplus, GSRS) |
Target
Agency Approved
IFNAR1
IFNAR1
Organism
Homo sapiens
Gene name
IFNAR1
Gene synonyms
IFNAR
NCBI Gene ID
Protein name
interferon alpha/beta receptor 1
Protein synonyms
alpha-type antiviral protein, beta-type antiviral protein, CRF2-1, Cytokine receptor class-II member 1, Cytokine receptor family 2 member 1, IFN-alpha/beta receptor 1, IFN-R-1, IFNalpha/beta receptor 1, interferon (alpha, beta and omega) receptor 1, interferon receptor 1, interferon-alpha/beta receptor alpha chain, interferon-beta receptor 1, Type I interferon receptor 1
Uniprot ID
Mouse ortholog
Ifnar1 (15975)
interferon alpha/beta receptor 1 (Q80UJ3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Saphnelo - AstraZeneca
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 735 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5 adverse events reported
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