Erenumab Explained

Type:mab
Mab Type:mab
Source:u
Target:CGRPR
Tradename:Aimovig
Dailymedid:Erenumab
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:Subcutaneous injection
Atc Prefix:N02
Atc Suffix:CD01
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[2]
Legal Us:Rx-only
Legal Us Comment:[3]
Legal Eu:Rx-only
Legal Status:Rx-only
Bioavailability:82% (estimated)
Metabolism:Proteolysis
Elimination Half-Life:28 days
Cas Number:1582205-90-0
Drugbank:DB14039
Chemspiderid:none
Unii:I5I8VB78VT
Kegg:D10928
Chembl:3833329
Synonyms:AMG-334, erenumab-aooe
C:6472
H:9964
N:1728
O:2018
S:50

Erenumab, sold under the brand name Aimovig, is a medication which blocks the calcitonin gene-related peptide receptor (CGRPR) for the prevention of migraine.[4] It is administered by subcutaneous injection.

Erenumab, which was developed by Amgen and Novartis, was approved in May 2018, and was the first CGRPR antagonist to be approved by the U.S. Food and Drug Administration. In 2020, it was the 234th most commonly prescribed medication in the United States, with more than 1million prescriptions.[5] [6]

Medical uses

Erenumab is indicated for the prevention of migraine in adults.

Side effects

Common side effects are constipation, pruritus, muscle spasms, as well as mild and mostly transient reactions at the injection site.

Interactions

Erenumab was shown not to interact with ethinylestradiol, norgestimate or the migraine drug sumatriptan. It is expected to generally have a low potential for interactions because it is not metabolized by cytochrome P450 enzymes.[7]

Pharmacology

Mechanism of action

Erenumab is a fully human monoclonal antibody blocking the calcitonin gene-related peptide receptor (CGRPR).[8] [9]

Pharmacokinetics

After subcutaneous injection, the erenumab has an estimated bioavailability of 82%. Highest blood plasma concentrations are reached after four to six days. Like other proteins, the substance is degraded by proteolysis to small peptides and amino acids. It has an elimination half-life of 28 days.

History

Erenumab was developed by Amgen Inc. in conjunction with Novartis.

In the phase III STRIVE clinical trial 955 patients were divided into three groups in a 1:1:1 ratio. Each group was injected subcutaneously monthly with 0, 70 or 140 mg erenumab over a period of 6 months. The results were measured as mean monthly migraine days in months 4, 5, and 6. At baseline the patients experienced between 4 and 14 migraine days per month with an average of 8.3. The medication significantly reduced the number of migraine days per month by 3.2 in the 70-mg group and 3.7 in the 140-mg group, versus 1.8 in the placebo (0-mg) group.[10]

Society and culture

Economics

As of 2018, the list price was reported to be per year.[11]

In the United Kingdom, Erenumab was approved by the Scottish Medicines Consortium, but the National Institute for Health and Care Excellence rejected the drug on the basis that its cost-effectiveness was not sufficiently proven.[12] [13]

Legal status

The United States Food and Drug Administration approved the medication for the preventive treatment of migraine in adults in May 2018. It was the first CGRPR antagonist to be approved.[14] It was approved for medical use in the European Union on 26 July 2018.[15] [16]

Names

Erenumab is the international nonproprietary name and the United States Adopted Name.[17] [18]

Notes and References

  1. Web site: Erenumab (Aimovig) Use During Pregnancy . Drugs.com . 17 April 2019 . 5 May 2020 . 29 November 2020 . https://web.archive.org/web/20201129054659/https://www.drugs.com/pregnancy/erenumab.html . live .
  2. Web site: Summary Basis of Decision (SBD) for Aimovig . . 23 October 2014 . 29 May 2022 . 31 May 2022 . https://web.archive.org/web/20220531070823/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00412&lang=en . live .
  3. Web site: Aimovig- erenumab-aooe injection Aimovig- erenumab-aooe injection, solution . DailyMed . 19 August 2022 . 29 September 2022 . 5 July 2022 . https://web.archive.org/web/20220705234005/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8 . live .
  4. Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA . 6 . A Controlled Trial of Erenumab for Episodic Migraine . The New England Journal of Medicine . 377 . 22 . 2123–2132 . November 2017 . 29171821 . 10.1056/NEJMoa1705848 . free . doi .
  5. Web site: The Top 300 of 2020 . ClinCalc . 7 October 2022.
  6. Web site: Erenumab - Drug Usage Statistics . ClinCalc . 7 October 2022.
  7. Web site: Aimovig: EPAR - Product Information. European Medicines Agency. 2018-08-08. 2 May 2019. 6 October 2018. https://web.archive.org/web/20181006214554/https://www.ema.europa.eu/documents/product-information/aimovig-epar-product-information_en.pdf. live.
  8. Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig (erenumab) For Migraine Patients With Multiple Treatment Failures . Amgen . PR Newswire . 17 April 2018 . 29 September 2022 . 11 November 2020 . https://web.archive.org/web/20201111140915/https://www.prnewswire.com/news-releases/amgen-presents-first-of-its-kind-data-at-aan-annual-meeting-reinforcing-robust-and-consistent-efficacy-of-aimovig-erenumab-for-migraine-patients-with-multiple-treatment-failures-300631565.html . live .
  9. Edvinsson L . CGRP Antibodies as Prophylaxis in Migraine . Cell . 175 . 7 . 1719 . December 2018 . 30550780 . 10.1016/j.cell.2018.11.049 . free . doi .
  10. http://www.pharmaworldmagazine.com/erenumab-prevent-migraine-results-phase-iii-stribe/ "Erenumab to prevent migraine: results from phase III STRIBE"
  11. News: F.D.A. Approves First Drug Designed to Prevent Migraines. Kolata. Gina. vanc. 2018-05-17. The New York Times. 2019-09-26. 11 May 2020. https://web.archive.org/web/20200511025517/https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html. live.
  12. News: 'Life-changing' migraine drug rejected for NHS. Gallagher. James. vanc. 2019-09-26. 2019-09-26. BBC News Online. 31 July 2021. https://web.archive.org/web/20210731173332/https://www.bbc.com/news/health-49831726. live.
  13. Web site: New migraine drug not cost-effective NICE says in draft guidance. NICE. 2019-09-26. 1 November 2020. https://web.archive.org/web/20201101004943/https://www.nice.org.uk/news/article/new-migraine-drug-not-cost-effective-nice-says-in-draft-guidance. live.
  14. News: FDA Approves First-in-Class Drug Erenumab (Aimovig) for Migraine Prevention. 17 May 2018. Medscape. 21 May 2018. 25 September 2019. https://web.archive.org/web/20190925144618/https://www.medscape.com/viewarticle/896851. live.
  15. Web site: Aimovig EPAR . European Medicines Agency (EMA) . 4 May 2020 . 17 October 2020 . https://web.archive.org/web/20201017051402/https://www.ema.europa.eu/en/medicines/human/EPAR/aimovig . live .
  16. Web site: First drug to prevent chronic migraines approved by EU . . 19 September 2018 . 31 July 2018 . 19 September 2018 . https://web.archive.org/web/20180919194417/https://www.theguardian.com/science/2018/jul/31/first-ever-pill-to-prevent-chronic-migraines-approved-by-eu . live .
  17. Web site: Statement On A Nonproprietary Name Adopted By The USAN Council - Erenumab . . 4 November 2018 . live . https://web.archive.org/web/20181104010146/https://searchusan.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Ferenumab.pdf . 2018-11-04 . 24 November 2015.
  18. World Health Organization . World Health Organization . International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 115 . WHO Drug Information . 30 . 2 . 2016 . 30 September 2022 . 5 February 2018 . https://web.archive.org/web/20180205073351/http://www.who.int/medicines/publications/druginformation/innlists/PL115.pdf . live .

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