Overview
Erenumab (AMG-334) (INN; trade name Aimovig) is a human monoclonal antibody designed specifically to bind and antagonize the calcitonin gene-related peptide receptor (CGRPR) as a means to prevent migraines. Aimovig, as released and marketed by Novartis and Amgen, is in fact a novel therapeutic approach as the first and only FDA approved treatment specifically developed to prevent migraine by blocking the CGRP receptor, which is believed to play a critical role in migraine . In particular, erenumab-aooe is a human immunoglobulin G2 monoclonal antibody that has high affinity binding to the CGRP receptor . The antibody is produced utlilizing recombinant DNA technology in Chinese hamster ovary cells . It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa .
Background
Erenumab (AMG-334) (INN; trade name Aimovig) is a human monoclonal antibody designed specifically to bind and antagonize the calcitonin gene-related peptide receptor (CGRPR) as a means to prevent migraines. Aimovig, as released and marketed by Novartis and Amgen, is in fact a novel therapeutic approach as the first and only FDA approved treatment specifically developed to prevent migraine by blocking the CGRP receptor, which is believed to play a critical role in migraine . In particular, erenumab-aooe is a human immunoglobulin G2 monoclonal antibody that has high affinity binding to the CGRP receptor . The antibody is produced utlilizing recombinant DNA technology in Chinese hamster ovary cells . It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa .
Indication
Erenumab is indicated for the preventative treatment of migraine in adults .
Associated Conditions
- Migraine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/13 | Phase 3 | Terminated | United States Naval Medical Center, Portsmouth | ||
2024/01/19 | N/A | ENROLLING_BY_INVITATION | |||
2023/11/29 | N/A | Recruiting | |||
2023/01/13 | Phase 2 | Recruiting | |||
2022/07/01 | N/A | Completed | |||
2022/03/17 | Phase 4 | Terminated | |||
2022/03/16 | N/A | Recruiting | Austrian Migraine Registry Collaboration | ||
2021/12/17 | Phase 2 | Terminated | |||
2021/12/02 | Phase 2 | Terminated | |||
2021/09/21 | N/A | Completed |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/26/2018 | ||
Authorised | 7/26/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140MG/ML | SIN15926P | INJECTION, SOLUTION | 140 MG/ML | 4/3/2020 | |
| AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED PEN 140MG/ML | SIN15925P | INJECTION, SOLUTION | 140 MG/ML | 4/3/2020 | |
| AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED PEN 70MG/ML | SIN15543P | INJECTION, SOLUTION | 70mg/ml | 9/21/2018 | |
| AIMOVIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 70MG/ML | SIN15545P | INJECTION, SOLUTION | 70mg/ml | 9/21/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Erenumab Injection | 国药准字SJ20230014 | 生物制品 | 注射剂 | 9/19/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AIMOVIG erenumab 140 mg/mL solution for injection in pre-filled pen | 309205 | Medicine | A | 10/29/2019 | |
| AIMOVIG erenumab 140 mg/mL solution for injection in pre-filled syringe | 309000 | Medicine | A | 10/29/2019 | |
| AIMOVIG erenumab (rch) 70 mg/mL solution for injection in pre-filled pen | 289959 | Medicine | A | 7/2/2018 | |
| AIMOVIG erenumab (rch) 70 mg/mL solution for injection in pre-filled syringe | 289960 | Medicine | A | 7/2/2018 |