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Fremanezumab

From Wikipedia, the free encyclopedia
Pharmaceutical biological monoclonal antibody

Pharmaceutical compound
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
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6470H9952N1716O2016S46
Molar mass145507.54 g·mol−1

Fremanezumab, sold under the brand nameAjovy, is amedication used to preventmigraines.[6][8] It is given bysubcutaneous injection (injection under the skin).[6][8]

The most common side effect is pain and redness at the site of injection.[8] Other side effects include allergic reactions.[8] It is acalcitonin gene-related peptide antagonist.[6][8]

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

Medical uses

[edit]

Fremanezumab isindicated for the preventive treatment of migraine in adults; and the preventive treatment of episodic migraine in children who are aged 6 to 17 years of age and who weigh 45 kilograms (99 lb) or more.[6]

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

Adverse effects

[edit]

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

Interactions

[edit]

Fremanezumab does not interact with other antimigraine drugs such astriptans,ergot alkaloids andanalgesics. It is expected to generally have a low potential for interactions, because it is not metabolized bycytochrome P450 enzymes.[6]

Pharmacology

[edit]

Mechanism of action

[edit]

Fremanezumab is a fully humanizedmonoclonal antibody directed againstcalcitonin gene-related peptides (CGRP) alpha and beta.[12] It potently and selectively binds to CGRPs, which prevents binding to receptors.

Pharmacokinetics

[edit]

Aftersubcutaneous injection, fremanezumab has abioavailability of 55–66%. Highest concentrations in the body are reached after five to seven days. Like other proteins, the substance is degraded byproteolysis to smallpeptides andamino acids, which are reused or excreted via the kidney. Theelimination half-life is estimated to be 31 days.[11]

Chemistry

[edit]

Fremanezumab is a humanized monoclonal antibody.[13] It is produced usingrecombinant DNA inChinese hamster ovary cells.[6]

History

[edit]

Fremanezumab was discovered and developed byRinat Neuroscience, was acquired byPfizer in 2006, and was then licensed toTeva.[14] It was approved by the USFood and Drug Administration in September 2018.[15] In March 2019, fremanezumab was approved for marketing and use in the European Union.[7][16]

References

[edit]
  1. ^"Fremanezumab Pregnancy and Breastfeeding Warnings".Drugs.com. 3 October 2018. Retrieved2 April 2020.
  2. ^"Summary Basis of Decision (SBD) for Ajovy".Health Canada. Retrieved29 May 2022.
  3. ^"Ajovy Product information".Health Canada. Retrieved31 May 2022.
  4. ^ab"Fremanezumab".NICE - National Institute for Health and Care Excellence. Retrieved25 June 2021.
  5. ^"Ajovy (fremanezumab) 225 mg Pre-filled Syringe for Injection - Summary of Product Characteristics (SmPC)".(emc). Retrieved27 September 2021.
  6. ^abcdefgh"Ajovy- fremanezumab-vfrm injection".DailyMed. U.S. National Library of Medicine. 5 February 2020. Retrieved2 April 2020.
  7. ^abc"Ajovy EPAR".European Medicines Agency (EMA). 29 January 2019. Retrieved2 April 2020.
  8. ^abcdef"Fremanezumab-vfrm Monograph for Professionals".Drugs.com. American Society of Health-System Pharmacists. Retrieved15 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. ^ab"Ajovy: EPAR - Product Information"(PDF).European Medicines Agency (EMA). 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. ^"Novel class of preventive treatments for migraine - Clinical Advisor". 18 May 2020.
  14. ^"Fremanezumab - Teva Pharmaceutical".
  15. ^"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 (Press release). Archived fromthe original on 8 October 2018. Retrieved7 October 2018.
  16. ^"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. 1 April 2019. Retrieved6 April 2019 – via Business Wire.
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