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Drug ReportsSarilumab
Kevzara(sarilumab)
Kevzara (sarilumab) is an antibody pharmaceutical. Sarilumab was first approved as Kevzara on 2017-05-22. It is used to treat rheumatoid arthritis in the USA. It has been approved in Europe to treat rheumatoid arthritis. The pharmaceutical is active against interleukin-6 receptor subunit alpha.
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Events Timeline
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Kevzara
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)
Sarilumab
Tradename
Proper name
Company
Number
Date
Products
KevzarasarilumabSanofiN-761037 RX2017-05-22
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
kevzaraBiologic Licensing Application2024-08-22
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AC: Interleukin inhibitors
— L04AC14: Sarilumab
HCPCS
No data
Clinical
Clinical Trials
69 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168HP_0001369M05-M14105154537
Rheumatoid arthritisD001172EFO_0000685M06.9103154434
AtherosclerosisD050197EFO_0003914I25.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382——153—29
Coronavirus infectionsD018352EFO_0007224B34.2—12—24
PneumoniaD011014EFO_0003106———1—12
Giant cell arteritisD013700EFO_1001209M31.6——2——2
Polymyalgia rheumaticaD011111EFO_0008518M35.3——2——2
InflammationD007249MP_0001845——11—12
ArteritisD001167EFO_0009011I77.6——1——1
Allergic contact dermatitisD017449—L23—11——1
DermatitisD003872HP_0011123L30.9—11——1
Contact dermatitisD003877—L25—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544——1——12
Triple negative breast neoplasmsD064726——12———2
Ovarian neoplasmsD010051EFO_0003893C5622———2
Endometrial neoplasmsD016889EFO_0004230—22———2
Fallopian tube neoplasmsD005185——22———2
Prostatic neoplasmsD011471—C6122———2
Castration-resistant prostatic neoplasmsD064129——22———2
Juvenile arthritisD001171EFO_1002007M08—2———2
Ankylosing spondylitisD013167EFO_0003898M45—2———2
SpondylarthritisD025241———2———2
Show 18 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175HP_0100526C34.901————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R58————11
Heart failureD006333HP_0001635I50————11
HypertensionD006973EFO_0000537I10————11
MenorrhagiaD008595EFO_0003945N92.0————11
Hemophilia aD006467EFO_0007267D66————11
PainD010146EFO_0003843R52————11
Down syndromeD004314EFO_0001064Q90————11
Blood coagulation disordersD001778EFO_0009314D68.9————11
Mucocutaneous lymph node syndromeD009080EFO_0004246M30.3————11
HyperaldosteronismD006929HP_0011736E26————11
Show 17 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSarilumab
INNsarilumab
Description
Sarilumab (human mab)
Classification
Antibody
Drug classantiviral (arildone derivatives); monoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108730
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDNU90V55F8I (ChemIDplus, GSRS)
Target
Agency Approved
IL6R
IL6R
Organism
Homo sapiens
Gene name
IL6R
Gene synonyms
NCBI Gene ID
Protein name
interleukin-6 receptor subunit alpha
Protein synonyms
CD126, CD126 antigen, gp80, IL-6 receptor subunit alpha, IL-6R 1, Membrane glycoprotein 80
Uniprot ID
Mouse ortholog
Il6ra (16194)
interleukin-6 receptor subunit alpha (P22272)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Kevzara – Regeneron Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,379 documents
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Safety
Black-box Warning
Black-box warning for: Kevzara
Adverse Events
Top Adverse Reactions
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14,728 adverse events reported
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