Identification
- Summary
Fremanezumab is a humanized monoclonal antibody directed against human calcitonin-gene related peptide to prevent migraines.
- Brand Names
- Ajovy
- Generic Name
- Fremanezumab
- DrugBank Accession Number
- DB14041
- Background
Fremanezumab is a humanized monoclonal antibody targeted against human calcitonin gene-related peptide (CGRP) for the prevention of migraine headaches.7 It was developed by Teva Pharmaceuticals USA and approved by the FDA in September 2018.8 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.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Structure
- Protein Chemical Formula
- Not Available
- Protein Average Weight
- 148000.0 Da
- Sequences
>fremanezumab|Heavy EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYWISWVRQAPGKGLEWVAEIRSESDASAT HYAEAVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCLAYFDYGLAIQNYWGQGTLVTV SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS VFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNST FRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKTKGQPREPQVYTLPPSREEMT KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQ GNVFSCSVMHEALHNHYTQKSLSLSPGK
>fremanezumab|Light EIVLTQSPATLSLSPGERATLSCKASKRVTTYVSWYQQKPGQAPRLLIYGASNRYLGIPA RFSGSGSGTDFTLTISSLEPEDFAVYYCSQSYNYPYTFGQGTKLEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Download FASTA Format- Synonyms
- Fremanezumab
- External IDs
- TEV-48125
Pharmacology
- Indication
Fremanezumab is indicated for the preventative treatment of migraine in adults.7
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
Fremanezumab is a subcutaneous injection that targets the calcitonin gene-related peptide (CGRP) ligand, preventing its binding to the CGRP receptor.3,7 It possesses a long duration of action requiring only monthly or quarterly administration and appears well-tolerated in clinical trials.7
- Mechanism of action
Studies dating back to 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after administration of antimigraine therapy such as sumatriptan.4 Moreover, research has shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.4 For these reasons, and despite the fact that their role in migraine headaches has not been entirely elucidated, CGRP and its receptors have become desirable targets for antimigraine therapies. Fremanezumab is a humanized monoclonal antibody directed against endogenous CGRP - it interferes with the activity of CGRP, preventing its downstream effects and ultimately mitigating the development of migraine headaches.7
Target Actions Organism ACalcitonin gene-related peptide 1 binderantibodyHumans ACalcitonin gene-related peptide 2 binderantibodyHumans - Absorption
Geometric mean ratios (GMRs) for Cmax for Japanese and Caucasian study subjects were 0.91, 1.04, and 1.14 for 225 mg, 675 mg, and 900 mg doses of fremanezumab 2. GMRs for AUC (0-inf) were 0.96, 1.09, and 0.98, respectively 2. Mean Tmax in a range of 5 to 11 days were similar across doses for both ethnicities as well 2.
- Volume of distribution
Fremanezumab has an apparent volume of distribution of approximately 6 liters which indicates very little distribution into tissue.7
- Protein binding
Data regarding protein binding of fremanezumab are not readily available.
- Metabolism
Like other monoclonal antibodies, fremanezumab is expected to undergo enzymatic proteolysis into smaller peptides and amino acids.7
- Route of elimination
Monoclonal antibody agents like fremanezumab are generally not eliminated via hepatic, renal, or biliary routes.9
- Half-life
The mean half-life recorded for fremanezumab was similar across doses for Japanese and Caucasian study subjects and was estimated to be approximately 31-39 days.2,7
- Clearance
The apparent clearance of fremanezumab is 0.141 L/day.7
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Information regarding overdose of fremanezumab is not readily available. The most common adverse events that led to discontinuation of fremanezumab therapy were injection site reactions including erythema, induration, and pain.7
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Fremanezumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Fremanezumab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Fremanezumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Fremanezumab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Fremanezumab. Amivantamab The risk or severity of adverse effects can be increased when Fremanezumab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Anifrolumab is combined with Fremanezumab. Ansuvimab The risk or severity of adverse effects can be increased when Fremanezumab is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Fremanezumab. Antilymphocyte immunoglobulin (horse) The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Fremanezumab. 
Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Ajovy Injection, solution 225 mg Subcutaneous Teva 2020-12-16 Not applicable EU 
Ajovy Solution 225 mg / 1.5 mL Subcutaneous TEVA Canada Limited 2021-04-01 Not applicable Canada 
Ajovy Injection 225 mg/1.5mL Subcutaneous Teva Pharmaceuticals USA, Inc. 2018-09-15 Not applicable US 
Ajovy Injection, solution 225 mg Subcutaneous Teva 2020-12-16 Not applicable EU Ajovy Solution 225 mg / 1.5 mL Subcutaneous TEVA Canada Limited 2020-08-04 Not applicable Canada Ajovy Injection, solution 225 mg Subcutaneous Teva 2020-12-16 Not applicable EU Ajovy Injection 225 mg/1.5mL Subcutaneous Teva Pharmaceuticals USA, Inc. 2020-03-29 Not applicable US Ajovy Filled Pen Injection, solution 225 mg Subcutaneous Teva 2020-12-16 Not applicable EU
Categories
- ATC Codes
- N02CD03 — Fremanezumab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Analgesics
- Antibodies
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antimigraine Preparations
- Blood Proteins
- Calcitonin Gene-Related Peptide (CGRP) Antagonists
- Calcitonin Gene-Related Peptide Receptor Antagonists
- Globulins
- Immunoglobulins
- Immunoproteins
- Nervous System
- Proteins
- Serum Globulins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- PF8K38CG54
- CAS number
- 1655501-53-3
References
- General References
- Pellesi L, Guerzoni S, Pini LA: Spotlight on Anti-CGRP Monoclonal Antibodies in Migraine: The Clinical Evidence to Date. Clin Pharmacol Drug Dev. 2017 Nov;6(6):534-547. doi: 10.1002/cpdd.345. Epub 2017 Apr 14. [Article]
- Cohen-Barak O, Weiss S, Rasamoelisolo M, Faulhaber N, Yeung PP, Loupe PS, Yoon E, Gandhi MD, Spiegelstein O, Aycardi E: A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia. 2018 Jan 1:333102418771376. doi: 10.1177/0333102418771376. [Article]
- Vollbracht S, Rapoport AM: New treatments for headache. Neurol Sci. 2014 May;35 Suppl 1:89-97. doi: 10.1007/s10072-014-1747-z. [Article]
- Deen M, Correnti E, Kamm K, Kelderman T, Papetti L, Rubio-Beltran E, Vigneri S, Edvinsson L, Maassen Van Den Brink A: Blocking CGRP in migraine patients - a review of pros and cons. J Headache Pain. 2017 Sep 25;18(1):96. doi: 10.1186/s10194-017-0807-1. [Article]
- Monteith D, Collins EC, Vandermeulen C, Van Hecken A, Raddad E, Scherer JC, Grayzel D, Schuetz TJ, de Hoon J: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the CGRP Binding Monoclonal Antibody LY2951742 (Galcanezumab) in Healthy Volunteers. Front Pharmacol. 2017 Oct 17;8:740. doi: 10.3389/fphar.2017.00740. eCollection 2017. [Article]
- JAMA Network: Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine [Link]
- FDA Approved Drug Products: Ajovy (fremanezumab-vfrm) subcutaneous injection [Link]
- FDA Drug Approval Package: Ajovy (fremanezumab-vfrm) [Link]
- Presentation on CGRP, MONOCLONAL ANTIBODIES AND SMALL MOLECULES (-GEPANTS) [File]
- External Links
- 2056691
- Wikipedia
- Fremanezumab
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Treatment Migraine 1 4 Completed Prevention Coronavirus Disease 2019 (COVID‑19) / Major Depressive Disorder (MDD) / Migraine 1 4 Completed Supportive Care Migraine 1 4 Recruiting Other Migraine / Sleep disorders and disturbances 1 4 Recruiting Treatment Chronic Migraine 1 3 Completed Treatment Migraine 5 3 Completed Treatment Prophylaxis of migraine headaches 1 3 Recruiting Treatment Migraine 4 3 Terminated Treatment Chronic Cluster Headache 1 3 Terminated Treatment Cluster Headache 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Subcutaneous 225 mg/1.5mL Injection, solution Parenteral; Subcutaneous 225 MG Injection, solution Subcutaneous 225 mg/1.5mL Injection, solution Subcutaneous 225 mg Solution Subcutaneous 225 mg / 1.5 mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- BinderAntibody
- General Function
- Receptor binding
- Specific Function
- CGRP induces vasodilation. It dilates a variety of vessels including the coronary, cerebral and systemic vasculature. Its abundance in the CNS also points toward a neurotransmitter or neuromodulato...
- Gene Name
- CALCA
- Uniprot ID
- P06881
- Uniprot Name
- Calcitonin gene-related peptide 1
- Molecular Weight
- 13897.755 Da
References
- FDA Approved Drug Products: Ajovy (fremanezumab-vfrm) subcutaneous injection [Link]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- BinderAntibody
- General Function
- Neuropeptide hormone activity
- Specific Function
- CGRP induces vasodilation. It dilates a variety of vessels including the coronary, cerebral and systemic vasculature. Its abundance in the CNS also points toward a neurotransmitter or neuromodulato...
- Gene Name
- CALCB
- Uniprot ID
- P10092
- Uniprot Name
- Calcitonin gene-related peptide 2
- Molecular Weight
- 13705.56 Da
References
- FDA Approved Drug Products: Ajovy (fremanezumab-vfrm) subcutaneous injection [Link]
Drug created at May 18, 2018 14:04 / Updated at June 03, 2022 07:24