Ajovy(fremanezumab)
Ajovy (fremanezumab) is an antibody pharmaceutical. Fremanezumab was first approved as Ajovy on 2018-09-14. 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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Ajovy
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)
Fremanezumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Ajovy | fremanezumab-vfrm | Teva | N-761089 RX | 2018-09-14 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ajovy | Biologic Licensing Application | 2020-10-27 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3031 | Injection, fremanezumab-vfrm, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered) |
Clinical
Clinical Trials
33 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 | 12 | 5 | 5 | 23 |
| Sleep wake disorders | D012893 | G47 | — | — | — | 1 | — | 1 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
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 | — | — | 3 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | 1 | — | — | — | 1 |
| Cadasil | D046589 | Orphanet_136 | I67.850 | — | 1 | — | — | — | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | — | 1 |
| Post-traumatic headache | D051298 | G44.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 1 | 1 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FREMANEZUMAB |
| INN | fremanezumab |
| Description | Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines in adults. It is given by injection under the skin.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1655501-53-3 |
| RxCUI | 2056691 |
| ChEMBL ID | CHEMBL4297756 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14041 |
| UNII ID | PF8K38CG54 (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
Ajovy - Teva
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 711 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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38 adverse events reported
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