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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
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
immune system diseasesD007154
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
Saphneloanifrolumab-fniaAstraZenecaN-761123 RX2021-07-30
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
saphneloBiologic Licensing Application2021-07-30
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA51: Anifrolumab
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 erythematosusD008180EFO_0002690M32345—113
Lupus nephritisD008181EFO_0005761—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.9—1———1
Sjogren's syndromeD012859EFO_0000699M35.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD0105991————1
Healthy volunteers/patients—1————1
Cardiovascular diseasesD002318EFO_0000319I981————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameANIFROLUMAB
INNanifrolumab
Description
Anifrolumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1326232-46-5
RxCUI—
ChEMBL IDCHEMBL2364653
ChEBI ID—
PubChem CID—
DrugBankDB78910
UNII ID38RL9AE51Q (ChemIDplus, GSRS)
Target
Agency Approved
IFNAR1
IFNAR1
Organism
Homo sapiens
Gene name
IFNAR1
Gene synonyms
IFNAR
NCBI Gene ID
3454
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
Q8WTZ2
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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