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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Events Timeline
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YTD
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2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Ajovy
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ajovy | Biologic Licensing Application | 2022-10-31 |
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
40 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 | 6 | 7 | 26 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | 1 | 1 | 2 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | 1 | 1 | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | 1 | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | 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 | 2 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 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
No data
Financial
Revenue by drug
$
€
£
â‚£
Ajovy – Teva
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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 922 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,501 adverse events reported
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