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Fremanezumab

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Fremanezumab
A Norwegian syringe of fremanezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCalcitonin gene-related peptide (CGRP) α, β
Clinical data
Trade namesAjovy
Other namesTEV-48125, fremanezumab-vfrm
AHFS/Drugs.comMonograph
MedlinePlusa618053
License data
Pregnancy
category
Routes of
administration		Subcutaneous
Drug classCalcitonin gene-related peptide antagonist
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability55–66%
MetabolismProteolysis
Elimination half-life30–31 days (estimated)
ExcretionKidney
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6470H9952N1716O2016S46
Molar mass145507.54 g·mol−1

Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines in adults.[8][6] It is given by injection under the skin.[8][6]

The most common side effect is pain and redness at the site of injection.[8] Other side effects include allergic reactions.[8] It is in the calcitonin gene-related peptide antagonist class of medications.[8]

It was approved for medical use in the United States in 2018,[8] the European Union in 2019,[7] the UK in 2020[4] and Argentina by September 2021.[9]

Medical uses

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Fremanezumab was shown to be effective in adults with four or more attacks per month.[10]

Adverse effects

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The most common adverse effects are reactions at the injection site, which occurred in 43 to 45% of people in studies (as compared to 38% under placebo). Hypersensitivity reactions occurred in fewer than 1% of patients.[6][11]

Interactions

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Fremanezumab does not interact with other antimigraine drugs such as triptans, ergot alkaloids and analgesics. It is expected to generally have a low potential for interactions because it is not metabolized by cytochrome P450 enzymes.[6]

Pharmacology

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Mechanism of action

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Fremanezumab is a fully humanized monoclonal antibody directed against calcitonin gene-related peptides (CGRP) alpha and beta.[12] The precise mechanism of action is unknown.[11] It can be given with a quarterly interval.

Pharmacokinetics

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After subcutaneous injection, fremanezumab has a bioavailability of 55–66%. Highest concentrations in the body are reached after five to seven days. Like other proteins, the substance is degraded by proteolysis to small peptides and amino acids, which are reused or excreted via the kidney. The elimination half-life is estimated to be 30 to 31 days.[11]

History

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Fremanezumab was discovered and developed by Rinat Neuroscience, was acquired by Pfizer in 2006, and was then licensed to Teva.[13] It was approved by the US Food and Drug Administration in September 2018.[14] In March 2019, fremanezumab was approved for marketing and use in the European Union.[7][15]

The drug has been and is still[when?] being evaluated for diseases other than migraine, where the endogenous substance CGRP has been implicated in the pathology.[citation needed] Teva is still[when?] developing it for episodic cluster headache but stopped development of fremanezumab for the treatment of chronic cluster headache in 2018 after the primary endpoint of a Phase III trial was not met.[16][needs update]

Chemistry

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Fremanezumab is a humanized monoclonal antibody.[17] It is produced using recombinant DNA in Chinese hamster ovary cells.[18]

References

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  1. ^ "Fremanezumab (Ajovy) Use During Pregnancy". Drugs.com. 3 October 2018. Retrieved 2 April 2020.
  2. ^ "Summary Basis of Decision (SBD) for Ajovy". Health Canada. Retrieved 29 May 2022.
  3. ^ "Ajovy Product information". Health Canada. Retrieved 31 May 2022.
  4. ^ a b "Fremanezumab". NICE - National Institute for Health and Care Excellence. Retrieved 25 June 2021.
  5. ^ "Ajovy (fremanezumab) 225 mg Pre-filled Syringe for Injection - Summary of Product Characteristics (SmPC)". (emc). Retrieved 27 September 2021.
  6. ^ a b c d e "Ajovy- fremanezumab-vfrm injection". DailyMed. U.S. National Library of Medicine. 5 February 2020. Retrieved 2 April 2020.
  7. ^ a b c "Ajovy EPAR". European Medicines Agency (EMA). 29 January 2019. Retrieved 2 April 2020.
  8. ^ a b c d e f "Fremanezumab-vfrm Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 15 July 2019.
  9. ^ "Migraña: en qué consiste el nuevo tratamiento para esta enfermedad frecuente e incapacitante". 12 September 2021.
  10. ^ Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. (May 2018). "Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial". JAMA. 319 (19): 1999–2008. doi:10.1001/jama.2018.4853. PMC 6583237. PMID 29800211.
  11. ^ a b c "Ajovy: EPAR - Product Information" (PDF). European Medicines Agency. 17 April 2019.
  12. ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1): 61–150. hdl:10665/330984.
  13. ^ "Fremanezumab - Teva Pharmaceutical".
  14. ^ "Teva Announces U.S. Approval of AJOVY (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults". Teva Pharmaceutical Industries Ltd Pharmaceutical Industries Ltd. Archived from the original on 8 October 2018. Retrieved 7 October 2018.
  15. ^ "Teva's AJOVY Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults" (Press release). Teva Pharmaceutical Industries Ltd. 1 April 2019. Retrieved 6 April 2019 – via Business Wire.
  16. ^ "Teva Pulls Out of Chronic Cluster Headache Trial of Fremanezumab". MD Magazine. Retrieved 19 June 2018.
  17. ^ "Novel class of preventive treatments for migraine - Clinical Advisor". 18 May 2020.
  18. ^ "AJOVY prescribing information" (PDF). Drugs@FDA: FDA-Approved Drugs. Retrieved 11 July 2020.
[edit]
  • "Fremanezumab". Drug Information Portal. U.S. National Library of Medicine.
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