Overview
Fremanezumab is a humanized monoclonal antibody targeted against human calcitonin gene-related peptide (CGRP) for the prevention of migraine headaches. It was developed by Teva Pharmaceuticals USA and approved by the FDA in September 2018. Along with other recently approved anti-CGRP therapies such as galcanezumab, erenumab, and the oral CGRP antagonist ubrogepant, fremanezumab represents an important step forward in the treatment and prevention of migraine headaches.
Background
Fremanezumab is a humanized monoclonal antibody targeted against human calcitonin gene-related peptide (CGRP) for the prevention of migraine headaches. It was developed by Teva Pharmaceuticals USA and approved by the FDA in September 2018. Along with other recently approved anti-CGRP therapies such as galcanezumab, erenumab, and the oral CGRP antagonist ubrogepant, fremanezumab represents an important step forward in the treatment and prevention of migraine headaches.
Indication
Fremanezumab is indicated for the preventative treatment of migraine in adults.
Associated Conditions
- Migraine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/19 | N/A | Recruiting | |||
2024/10/26 | N/A | Recruiting | |||
2024/02/06 | Phase 4 | Recruiting | |||
2024/01/19 | N/A | ENROLLING_BY_INVITATION | |||
2023/12/18 | Phase 4 | Recruiting | |||
2022/07/14 | Phase 3 | Completed | |||
2022/04/22 | N/A | Recruiting | |||
2022/03/17 | Phase 4 | Terminated | |||
2022/03/16 | N/A | Recruiting | Austrian Migraine Registry Collaboration | ||
2021/01/05 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 51759-202 | SUBCUTANEOUS | 225 mg in 1.5 mL | 4/12/2023 | |
| Teva Pharmaceuticals USA, Inc. | 51759-204 | SUBCUTANEOUS | 225 mg in 1.5 mL | 4/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/28/2019 | ||
Authorised | 3/28/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AJOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 225 MG/1.5ML | SIN16344P | INJECTION, SOLUTION | 225 mg/1.5ml | 10/4/2021 | |
| AJOVY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 225 MG/1.5ML | SIN15937P | INJECTION, SOLUTION | 225 mg/1.5 ml | 5/8/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| AJOVY fremanezumab 225 mg/1.5 mL solution for injection in a pre-filled syringe | 308630 | Medicine | A | 9/20/2019 | |
| AJOVY fremanezumab 225 mg/1.5 mL solution for injection in an autoinjector | 342612 | Medicine | A | 6/2/2021 |