Fremanezumab

Fremanezumab
A Norwegian syringe of fremanezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCalcitonin gene-related peptide (CGRP) α, β
Names
Trade namesAjovy
Other namesTEV-48125, fremanezumab-vfrm
Clinical data
Drug classCalcitonin gene-related peptide antagonist
Main usesPrevent migraines[1]
Side effectsPain at site of injection, allergic reactions[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
    Routes of
    use    		Subcutaneous injection
    Typical dose225 mg q month[3]
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa618053
    Legal
    License data
    Legal status
    • AU: S4 (Prescription only)
    • UK: [4][5]
    • US: ℞-only [6]
    • EU: Rx-only [7]
    • In general: ℞ (Prescription only)
    Pharmacokinetics
    Bioavailability55–66%
    MetabolismProteolysis
    Elimination half-life30–31 days (estimated)
    ExcretionKidney
    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.[1][6] It not a preferred option due to the cost.[1] It is given by injection under the skin.[1][6]

    Common side effect include pain and redness at the site of injection.[1] Other side effects may include allergic reactions.[1] Safety in pregnancy and breastfeeding is unclear.[1] It is in the calcitonin gene-related peptide (CGRP) antagonist class of medications.[1]

    Fremanezumab was approved for medical use in the United States in 2018,[1] Europe in 2019,[7] and the UK in 2020.[4] In the United States it costs 625 USD per month as of 2021.[8] In the United Kingdom this amount costs the NHS about £450.[3]

    Medical uses

    Fremanezumab was shown to be effective in adults with four or more attacks per month.[9]

    Dosage

    It is given at a dose of 225 mg once per month or 675 mg once every 3 months.[1]

    Side effects

    The most common side 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][10]

    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.[6]

    Pharmacology

    Mechanism of action

    Fremanezumab is a fully humanized monoclonal antibody directed against calcitonin gene-related peptides (CGRP) alpha and beta.[11] The precise mechanism of action is unknown.[10] It is the only approved anti-CGRP monoclonal antibody that 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.[10]

    Chemistry

    Fremanezumab is a humanized monoclonal antibody.[12] It is produced using recombinant DNA in Chinese hamster ovary cells [13]

    History

    Fremanezumab was discovered and developed by Rinat Neuroscience, was acquired by Pfizer in 2006, and was then licensed to Teva.[14] It was approved by the US Food and Drug Administration in September 2018.[15] In March 2019, fremanezumab was approved for marketing and use in the European Union.[7][16]

    The drug has been evaluated in episodic cluster headache but stopped development in 2018 after the primary endpoint of a Phase III trial was not met.[17]

    References

    1. 1 2 3 4 5 6 7 8 9 10 11 "Fremanezumab-vfrm Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 2 January 2022. Retrieved 15 July 2019.
    2. ↑ "Fremanezumab (Ajovy) Use During Pregnancy". Drugs.com. 3 October 2018. Archived from the original on 20 October 2020. Retrieved 2 April 2020.
    3. 1 2 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 498. ISBN 978-0857114105.
    4. 1 2 "Fremanezumab". NICE - National Institute for Health and Care Excellence. Archived from the original on 18 November 2021. Retrieved 25 June 2021.
    5. ↑ "Ajovy (fremanezumab) 225 mg Pre-filled Syringe for Injection - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 28 September 2021. Retrieved 27 September 2021.
    6. 1 2 3 4 5 "Ajovy- fremanezumab-vfrm injection". DailyMed. 5 February 2020. Archived from the original on 2 January 2022. Retrieved 2 April 2020.
    7. 1 2 3 "Ajovy EPAR". European Medicines Agency (EMA). 29 January 2019. Archived from the original on 29 November 2021. Retrieved 2 April 2020.
    8. ↑ "Fremanezumab Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 12 December 2021.
    9. ↑ Dodick, David W.; Silberstein, Stephen D.; Bigal, Marcelo E.; Yeung, Paul P.; Goadsby, Peter J.; Blankenbiller, Tricia; Grozinski-Wolff, Melissa; Yang, Ronghua; Ma, Yuju; Aycardi, Ernesto (15 May 2018). "Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine". JAMA. 319 (19): 1999–2008. doi:10.1001/jama.2018.4853. PMC 6583237. PMID 29800211.
    10. 1 2 3 "Ajovy: EPAR - Product Information" (PDF). European Medicines Agency. 17 April 2019. Archived (PDF) from the original on 2 January 2022. Retrieved 5 October 2021.
    11. ↑ 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.
    12. ↑ "Novel class of preventive treatments for migraine - Clinical Advisor". 18 May 2020. Archived from the original on 2 January 2022. Retrieved 5 October 2021.
    13. ↑ "AJOVY prescribing information" (PDF). Drugs@FDA: FDA-Approved Drugs. Archived (PDF) from the original on 2 July 2021. Retrieved 11 July 2020.
    14. ↑ "Fremanezumab - Teva Pharmaceutical". Archived from the original on 20 October 2019. Retrieved 5 October 2021.
    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 Industries Ltd Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd Pharmaceutical Industries Ltd. Archived from the original on 8 October 2018. Retrieved 7 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 Industries Ltd. 1 April 2019. Archived from the original on 27 July 2019. Retrieved 6 April 2019 – via Business Wire.
    17. ↑ "Teva Pulls Out of Chronic Cluster Headache Trial of Fremanezumab". MD Magazine. Archived from the original on 23 July 2020. Retrieved 19 June 2018.
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