Fremanezumab Explained

Type:mab
Mab Type:mab
Source:zu
Target:Calcitonin gene-related peptide (CGRP) α, β
Tradename:Ajovy
Licence Eu:yes
Dailymedid:Fremanezumab
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:Subcutaneous
Class:Calcitonin gene-related peptide antagonist
Atc Prefix:N02
Atc Suffix:CD03
Legal Au:S4
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[2] [3]
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Bioavailability:55–66%
Metabolism:Proteolysis
Elimination Half-Life:30–31 days (estimated)
Excretion:Kidney
Cas Number:1655501-53-3
Drugbank:DB14041
Chemspiderid:none
Unii:PF8K38CG54
Kegg:D11055
Synonyms:TEV-48125, fremanezumab-vfrm
C:6470
H:9952
N:1716
O:2016
S:46

Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines in adults.[5] [6] It is given by injection under the skin.[5]

The most common side effect is pain and redness at the site of injection.[5] Other side effects include allergic reactions.[5] It is in the calcitonin gene-related peptide antagonist class of medications.[5]

It was approved for medical use in the United States in 2018,[5] the European Union in 2019,[7] the UK in 2020[8] and Argentina by September 2021.[9]

Medical uses

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

Adverse effects

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.[11]

Interactions

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.

Pharmacology

Mechanism of action

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. It can be given with a quarterly interval.

Pharmacokinetics

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.

History

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.[15]

The drug has been and is still being evaluated for diseases other than migraine, where the endogenous substance CGRP has been implicated in the pathology. Teva is still 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]

Chemistry

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

External links

Notes and References

  1. Web site: Fremanezumab (Ajovy) Use During Pregnancy . Drugs.com . 3 October 2018 . 2 April 2020.
  2. Web site: Summary Basis of Decision (SBD) for Ajovy . Health Canada . 29 May 2022.
  3. Web site: Ajovy Product information . . 31 May 2022.
  4. Web site: Ajovy (fremanezumab) 225 mg Pre-filled Syringe for Injection - Summary of Product Characteristics (SmPC) . (emc) . 27 September 2021.
  5. Web site: Fremanezumab-vfrm Monograph for Professionals . Drugs.com . American Society of Health-System Pharmacists . 15 July 2019 .
  6. Web site: Ajovy- fremanezumab-vfrm injection . DailyMed . U.S. National Library of Medicine . 5 February 2020 . 2 April 2020.
  7. Web site: Ajovy EPAR . European Medicines Agency (EMA) . 29 January 2019 . 2 April 2020.
  8. Web site: Fremanezumab . NICE - National Institute for Health and Care Excellence . 25 June 2021.
  9. Web site: 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, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E . 6 . Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial . JAMA . 319 . 19 . 1999–2008 . May 2018 . 29800211 . 6583237 . 10.1001/jama.2018.4853 . free .
  11. Web site: Ajovy: EPAR - Product Information. 2019-04-17. European Medicines Agency.
  12. ((World Health Organization)). International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77. WHO Drug Information. 31. 1. 2017. 61–150. 10665/330984. free .
  13. Web site: Fremanezumab - Teva Pharmaceutical.
  14. Web site: 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 . 7 October 2018 . 8 October 2018 . https://web.archive.org/web/20181008022718/https://www.tevapharm.com/news/teva_announces_u_s_approval_of_ajovytm_fremanezumab_vfrm_injection_the_first_and_only_anti_cgrp_treatment_with_both_quarterly_and_monthly_dosing_for_the_preventive_treatment_of_migraine_in_adults_09_18.aspx . dead .
  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 . Business Wire . Teva Pharmaceutical Industries Ltd. . 1 April 2019 . 6 April 2019.
  16. Web site: Teva Pulls Out of Chronic Cluster Headache Trial of Fremanezumab. MD Magazine. 2018-06-19.
  17. Web site: Novel class of preventive treatments for migraine - Clinical Advisor. 18 May 2020.
  18. Web site: AJOVY prescribing information. July 11, 2020. Drugs@FDA: FDA-Approved Drugs.