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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FDA approval date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Vyvgart
CombinationsVyvgart hytrulo
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vyvgart | Biologic Licensing Application | 2024-10-21 |
| vyvgart hytrulo | Biologic Licensing Application | 2024-08-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| extravasation of diagnostic and therapeutic materials | — | D005119 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
efgartigimod alfa / hyaluronidase, Vyvgart Hytrulo, Argenx BV | |||
| 2030-06-20 | Orphan excl. | ||
efgartigimod alfa, Vyvgart, Argenx BV | |||
| 2028-12-17 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9332 | Injection, efgartigimod alfa-fcab, 2mg |
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | 5 | 11 | 1 | 3 | 17 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | 2 | — | 1 | — | 3 |
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | 2 | — | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscle weakness | D018908 | HP_0001324 | — | — | 5 | 11 | — | 1 | 14 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | 6 | — | — | 7 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 1 | 6 | — | — | 7 |
| Paresis | D010291 | HP_0001269 | — | — | 1 | 2 | — | — | 3 |
| Pemphigus | D010392 | EFO_1000749 | L10 | — | 1 | 2 | — | — | 3 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 2 | 1 | — | — | 3 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | 2 | — | — | 2 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | 1 | 2 | — | — | 2 |
| Dermatomyositis | D003882 | EFO_0000398 | M33 | — | 1 | 2 | — | — | 2 |
| Muscular diseases | D009135 | HP_0003198 | G72.9 | — | 1 | 2 | — | — | 2 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 6 | — | — | — | 6 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | — | 2 | — | — | — | 2 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | 2 | — | — | — | 2 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 1 | — | — | 1 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | — | 1 | — | — | 1 | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | 1 | 2 |
| Guillain-barre syndrome | D020275 | EFO_0007292 | G61.0 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 1 | — | — | — | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Efgartigimod alfa |
| INN | efgartigimod 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 class | Fc fusion protein; immunomodulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1821402-21-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297551 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15270 |
| UNII ID | 961YV2O515 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
FCGRT
FCGRT
Organism
Homo sapiens
Gene name
FCGRT
Gene synonyms
FCRN
NCBI Gene ID
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
Mouse ortholog
Fcgrt (14132)
IgG receptor FcRn large subunit p51 (Q9R2A5)
Variants
No data
Financial
Revenue by drug
$
€
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â‚£
Vyvgart – Zai Lab
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 404 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,296 adverse events reported
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