Vyepti(eptinezumab)
Vyepti (eptinezumab) is an antibody pharmaceutical. Eptinezumab was first approved as Vyepti on 2020-02-21. It has been approved in Europe to treat migraine disorders. The pharmaceutical is active against calcitonin; calcitonin gene-related peptide 1.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Vyepti
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)
Eptinezumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Vyepti | eptinezumab-jjmr | Lundbeck | N-761119 RX | 2020-02-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vyepti | Biologic Licensing Application | 2020-02-21 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3032 | Injection, eptinezumab-jjmr, 1 mg |
Clinical
Clinical Trials
24 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | 3 | 1 | 9 | 2 | 2 | 17 |
| Secondary headache disorders | D051271 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | 2 | — | — | 2 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | EPTINEZUMAB |
| INN | eptinezumab |
| Description | Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. It is administered by intravenous infusion.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833320 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14040 |
| UNII ID | 8202AY8I7H (ChemIDplus, GSRS) |
Target
Agency Approved
CALCA
CALCA
Organism
Homo sapiens
Gene name
CALCA
Gene synonyms
CALC1
NCBI Gene ID
Protein name
calcitonin; calcitonin gene-related peptide 1
Protein synonyms
Alpha-type CGRP, calcitonin 1, Calcitonin gene-related peptide I, calcitonin/calcitonin-related polypeptide, alpha, CGRP-I, katacalcin
Uniprot ID
Mouse ortholog
Calca (12310)
calcitonin gene-related peptide 1 (Q99JA0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
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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29,641 adverse events reported
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