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Vyvgart(efgartigimod alfa)
Vyvgart (efgartigimod alfa) is a protein pharmaceutical. Efgartigimod alfa was first approved as Vyvgart on 2021-12-17. It has been approved in Europe to treat myasthenia gravis. It is known to target IgG receptor FcRn large subunit p51.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Vyvgart
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)
Efgartigimod alfa
Tradename
Proper name
Company
Number
Date
Products
Vyvgartefgartigimod alfa-fcabArgenxN-761195 RX2021-12-17
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
vyvgartBiologic Licensing Application2022-02-09
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
efgartigimod alfa, Vyvgart, Argenx BV
2028-12-17Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
33 clinical trials
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Mock data
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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
Myasthenia gravisD009157EFO_0004991G70.0—37—19
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—15——6
PemphigusD010392EFO_1000749L10—12——3
Bullous pemphigoidD010391EFO_0007187L12—12——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic inflammatory demyelinating polyradiculoneuropathyD020277EFO_1000868G61.81—2———2
Guillain-barre syndromeD020275EFO_0007292G61.0—1———1
Postural orthostatic tachycardia syndromeD054972G90.A—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEFGARTIGIMOD ALFA
INNefgartigimod alfa
Description
Efgartigimod alfa, sold under the brand name Vyvgart, is a medication used to treat myasthenia gravis. Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication. It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood. The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis. It is also available coformulated with hyaluronidase.
Classification
Protein
Drug classFc fusion protein; immunomodulators
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1821402-21-4
RxCUI—
ChEMBL IDCHEMBL4297551
ChEBI ID—
PubChem CID—
DrugBankDB15270
UNII ID961YV2O515 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FCGRT
FCGRT
Organism
Homo sapiens
Gene name
FCGRT
Gene synonyms
FCRN
NCBI Gene ID
2217
Protein name
IgG receptor FcRn large subunit p51
Protein synonyms
Fc fragment of IgG receptor and transporter, Fc fragment of IgG, receptor, transporter, alpha, FcRn alpha chain, heavy chain of the major histocompatibility complex class I-like Fc receptor, IgG Fc fragment receptor transporter alpha chain, immunoglobulin receptor, intestinal, heavy chain, major histocompatibility complex class I-like Fc receptor, Neonatal Fc receptor, neonatal Fc-receptor for Ig, transmembrane alpha chain of the neonatal receptor
Uniprot ID
Q9NZ19
Mouse ortholog
Fcgrt (14132)
IgG receptor FcRn large subunit p51 (Q9R2A5)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 23 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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