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{{Short description|Chemical compound}}
 
 
{{Use dmy dates|date=December 2019}}
{{Infobox drug
| drug_name =
| INN =
| type = mab
| image = File:Aimovig Autoinjector.jpg
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| Drugs.com = {{drugs.com|monograph|erenumab-aooe}}
| MedlinePlus = a618029
| licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_EU = yes
| DailyMedID = Erenumab
| license_US = Aimovig
| pregnancy_AU = B1
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Erenumab (Aimovig) Use During Pregnancy | website=Drugs.com | date=17 April 2019 | url=https://www.drugs.com/pregnancy/erenumab.html | access-date=5 May 2020 | archive-date=29 November 2020 | archive-url=https://web.archive.org/web/20201129054659/https://www.drugs.com/pregnancy/erenumab.html | url-status=live }}</ref>
| pregnancy_US = N
| pregnancy_US_comment = <ref name="Drugs.com pregnancy" />
| pregnancy_category=
| dependency_liability =
| addiction_liability =
| routes_of_administration = [[Subcutaneous injection]]
| class =
| ATCvet =
| ATC_prefix = N02
| ATC_suffix = CD01
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | title=Summary Basis of Decision (SBD) for Aimovig | website=[[Health Canada]] | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00412&lang=en | access-date=29 May 2022 | archive-date=31 May 2022 | archive-url=https://web.archive.org/web/20220531070823/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00412&lang=en | url-status=live }}</ref>
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment =
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| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Aimovig FDA label">{{cite web | title=Aimovig- erenumab-aooe injection Aimovig- erenumab-aooe injection, solution | website=DailyMed | date=19 August 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8 | access-date=29 September 2022 | archive-date=5 July 2022 | archive-url=https://web.archive.org/web/20220705234005/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8 | url-status=live }}</ref>
| legal_US_comment =
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Aimovig EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
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<!-- Identifiers -->
| CAS_number_Ref =
| CAS_number = 1582205-90-0
| CAS_supplemental =
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| PubChemSubstance =
| IUPHAR_ligand =
| DrugBank_Ref =
| DrugBank = DB14039
| ChemSpiderID_Ref =
| ChemSpiderID = none
| UNII_Ref =
| UNII = I5I8VB78VT
| KEGG_Ref =
| KEGG = D10928
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref =
| ChEMBL = 3833329
| NIAID_ChemDB =
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}}
 
'''Erenumab''', sold under the brand name '''Aimovig''', is a [[medication]] which targetsblocks the [[calcitonin gene-related peptide receptor]] (CGRPR) for the prevention of [[migraine]].<ref>{{cite web |titlename=Statement"Aimovig OnFDA Alabel" Nonproprietary Name Adopted By The USAN Council - Erenumab |url=https://searchusan.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Ferenumab.pdf |publisher=[[American Medical Association]] |access-date=4 November 2018 |url-status=live |archive-url=https://web.archive.org/web/20181104010146/https://searchusan.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Ferenumab.pdf |archive-date=2018-11-04 |date=November 24, 2015}}</ref><ref>{{cite journal | author name="Aimovig WorldEPAR" Health Organization | author-link = World Health Organization | title = International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 115 | journal = WHO Drug Information | volume = 30 | issue = 2 | year = 2016 | url =https://www.who.int/medicines/publications/druginformation/innlists/PL115.pdf }}</ref><ref name="Goadsby">{{cite journal | vauthors = Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA | display-authors = 6 | title = A Controlled Trial of Erenumab for Episodic Migraine | journal = The New England Journal of Medicine | volume = 377 | issue = 22 | pages = 2123–2132 | date = November 2017 | pmid = 29171821 | doi = 10.1056/NEJMoa1705848 | doi-access = free }}</ref>| It was one of the first four CGRPR antagonists to be FDA approved in May, 2018.<ref name="Medscape">{{cite news|title=FDA Approves First-in-Classlink Drug Erenumab (Aimovig) for Migraine Prevention|date=May 17,doi 2018|url=https://www.medscape.com/viewarticle/896851|work=[[Medscape]]}}</ref><ref>{{Cite web|date=2021-02-01|title=13 Things You Need to Know About Aimovig|url=https://www.migraineagain.com/aimovig-guide/|access-date=2021-03-17|website=Migraine Again|language=en-US}}</ref> It is aadministered form ofby [[monoclonalsubcutaneous antibody therapyinjection]] in which antibodies are used to block the [[Receptor (biochemistry)|receptors]] for the protein [[Calcitonin gene-related peptide|CGRP]], thought to play a major role in starting migraines.<ref>{{cite journal | vauthors name="Aimovig EdvinssonFDA Llabel" | title = CGRP Antibodies as Prophylaxis in Migraine | journal = Cell | volume = 175 | issue = 7 | pages = 1719 | date = December 2018 | pmid = 30550780 | doi = 10.1016/j.cell.2018.11.049 | doi-access><ref name="Aimovig freeEPAR" }}</ref>
 
Erenumab, which was developed by [[Amgen]] and [[Novartis]],<ref name="Goadsby" /> was approved in May 2018, and was the first CGRPR antagonist to be approved by the U.S. [[Food and Drug Administration]].<ref name="Medscape" /> In 2020, it was the 234th most commonly prescribed medication in the United States, with more than 1{{nbsp}}million prescriptions.<ref>{{cite web | title = The Top 300 of 2020 | url = https://clincalc.com/DrugStats/Top300Drugs.aspx | website = ClinCalc | access-date = 7 October 2022}}</ref><ref>{{cite web | title = Erenumab - Drug Usage Statistics | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Erenumab | access-date = 7 October 2022}}</ref>
The U.S. [[Food and Drug Administration]] (FDA) considers it to be a first-in-class medication.<ref>{{cite report | title=New Drug Therapy Approvals 2018 | website=U.S. [[Food and Drug Administration]] (FDA) | date=January 2019 | url=https://www.fda.gov/media/120357/download | format=PDF | access-date=16 September 2020}}</ref>
 
== Medical uses ==
Erenumab is indicated for the prevention of [[migraine]] in adults.<ref name="MedscapeAimovig FDA label" /><ref name="Aimovig EPAR" />
 
It is administered by [[subcutaneous injection]].<ref name=drugs>{{cite web|title=Aimovig (erenumab-aooe) FDA Approval History|url=https://www.drugs.com/history/aimovig.html|website=Drugs.com}}</ref>
 
== Side effects ==
Common side effects are [[constipation]], [[pruritus]], muscle [[spasm]]s, as well as mild and mostly transient [[injection site reaction|reactions at the injection site]].<ref name="Aimovig EPAR" /><ref name="EPAR" />
 
== Interactions ==
Erenumab was shown not to interact with [[ethinyl estradiol|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.<ref name="EPAR">{{cite web|url=https://www.ema.europa.eu/documents/product-information/aimovig-epar-product-information_en.pdf|title=Aimovig: EPAR - Product Information|publisher=[[European Medicines Agency]]|date=2018-08-08|access-date=2 May 2019|archive-date=6 October 2018|archive-url=https://web.archive.org/web/20181006214554/https://www.ema.europa.eu/documents/product-information/aimovig-epar-product-information_en.pdf|url-status=live}}</ref>
 
== Pharmacology ==
=== Mechanism of action ===
Erenumab is a fully human [[monoclonal antibody]] blocking the [[calcitonin gene-related peptide receptor]] (CGRPR).<ref name=drugs"Aimovig FDA label" /><ref>{{cite webpress release | title=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 | publisher=Amgen | via=PR Newswire | date=17 April 2018 | url=https://www.drugsprnewswire.com/clinical_trialsnews-releases/amgen-presents-first-of-its-kind-data-at-aan-annual-meeting-reinforcing-robust-and-consistent-efficacy-of-aimovig-17781erenumab-for-migraine-patients-with-multiple-treatment-failures-300631565.html |website access-date=Drugs29 September 2022 | archive-date=11 November 2020 | archive-url=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 | url-status=live }}</ref><ref>{{cite journal | vauthors = Edvinsson L | title = CGRP Antibodies as Prophylaxis in Migraine | journal = Cell | volume = 175 | issue = 7 | pages = 1719 | date =April 17,December 2018 | pmid = 30550780 | doi = 10.1016/j.cell.2018.11.049 | doi-access = free | title-link = doi }}</ref>
 
=== Pharmacokinetics ===
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== History ==
Erenumab was developed by [[Amgen]]|Amgen Inc.]] in conjunction with [[Novartis]].<ref name="Goadsby" />▼
=== Development ===▼
▲Erenumab was developed by [[Amgen]] Inc in conjunction with [[Novartis]].<ref name="Goadsby" />
 
In the [[Phase III clinical trials|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&nbsp;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.<ref name="Goadsby" /><ref>[http://www.pharmaworldmagazine.com/erenumab-prevent-migraine-results-phase-iii-stribe/ "Erenumab to prevent migraine: results from phase III STRIBE"] {{Webarchive|url=https://web.archive.org/web/20180813072615/http://www.pharmaworldmagazine.com/erenumab-prevent-migraine-results-phase-iii-stribe/ |date=13 August 2018 }}, ''Pharma World'', 14 December 14, 2017.</ref>
 
=== ApprovalSociety and marketingculture ===
▲=== DevelopmentEconomics ===
The United States [[Food and Drug Administration]] (FDA) approved the medication for the preventive treatment of migraine in adults on May 17, 2018. The list price was reported to be {{US$|6,900}} per year.<ref>{{Cite news|url=https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html|title=F.D.A. Approves First Drug Designed to Prevent Migraines|last=Kolata|first=Gina | name-list-style = vanc |date=2018-05-17|work=[[The New York Times]]|access-date=2019-09-26|issn=0362-4331}}</ref> It was approved for medical use in the European Union on July 26, 2018.<ref name="Aimovig EPAR">{{cite web | title=Aimovig EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/aimovig | access-date=4 May 2020}}</ref><ref>{{cite web |title=First drug to prevent chronic migraines approved by EU |url=https://www.theguardian.com/science/2018/jul/31/first-ever-pill-to-prevent-chronic-migraines-approved-by-eu |website=[[The Guardian]] |access-date=19 September 2018 |date=31 July 2018}}</ref>▼
As of 2018, the list price was reported to be {{US$|6,900}} per year.<ref>{{Cite news|url=https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html|title=F.D.A. Approves First Drug Designed to Prevent Migraines|last=Kolata|first=Gina|name-list-style=vanc|date=2018-05-17|work=[[The New York Times]]|access-date=2019-09-26|archive-date=11 May 2020|archive-url=https://web.archive.org/web/20200511025517/https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html|url-status=live}}</ref>
 
In the United Kingdom, Erenumab was approved by the [[Scottish Medicines Consortium]], but the [[National Institute of Health and Care Excellence|National Institute for Health and Care Excellence]] rejected the drug on the basis that its cost-effectiveness was not sufficiently proven.<ref>{{Cite news|url=https://www.bbc.com/news/health-49831726|title='Life-changing' migraine drug rejected for NHS|last=Gallagher|first=James | name-list-style = vanc |date=2019-09-26|access-date=2019-09-26|website=[[BBC News Online]]|archive-date=31 July 2021|archive-url=https://web.archive.org/web/20210731173332/https://www.bbc.com/news/health-49831726|url-status=live}}</ref><ref>{{Cite web|url=https://www.nice.org.uk/news/article/new-migraine-drug-not-cost-effective-nice-says-in-draft-guidance|title=New migraine drug not cost-effective NICE says in draft guidance|website=NICE|access-date=2019-09-26|archive-date=1 November 2020|archive-url=https://web.archive.org/web/20201101004943/https://www.nice.org.uk/news/article/new-migraine-drug-not-cost-effective-nice-says-in-draft-guidance|url-status=live}}</ref>
 
=== ReceptionLegal status ===
▲The United States [[Food and Drug Administration]] (FDA) approved the medication for the preventive treatment of migraine in adults onin May 17, 2018. TheIt listwas pricethe wasfirst reportedCGRPR antagonist to be {{US$|6,900}} per yearapproved.<ref name="Medscape">{{Citecite news|url=https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html|title=F.D.A.FDA Approves First-in-Class Drug DesignedErenumab to(Aimovig) Preventfor Migraines|last=Kolata|first=GinaMigraine Prevention| name-list-style date=17 vancMay 2018|dateurl=2018-05-17https://www.medscape.com/viewarticle/896851|work=[[The New York TimesMedscape]]|access-date=201921 May 2018|archive-09-26date=25 September 2019|issnarchive-url=0362https://web.archive.org/web/20190925144618/https://www.medscape.com/viewarticle/896851|url-4331status=live}}</ref> It was approved for medical use in the European Union on July 26, July 2018.<ref name="Aimovig EPAR">{{cite web | title=Aimovig EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/aimovig | access-date=4 May 2020 | archive-date=17 October 2020 | archive-url=https://web.archive.org/web/20201017051402/https://www.ema.europa.eu/en/medicines/human/EPAR/aimovig | url-status=live }}</ref><ref>{{cite web |title=First drug to prevent chronic migraines approved by EU |url=https://www.theguardian.com/science/2018/jul/31/first-ever-pill-to-prevent-chronic-migraines-approved-by-eu |website=[[The Guardian]] |access-date=19 September 2018 |date=31 July 2018 |archive-date=19 September 2018 |archive-url=https://web.archive.org/web/20180919194417/https://www.theguardian.com/science/2018/jul/31/first-ever-pill-to-prevent-chronic-migraines-approved-by-eu |url-status=live }}</ref>
In July 2019, a report was published in [[American Headache Society]]'s Annual Scientific Meeting where it was said that for some patients who took Aimovig got "favorable responses" while others faced "limited benefits".<ref>{{Cite journal|date=2019|title=61st Annual Scientific Meeting American Headache Society® July 11 -14 2019 Pennsylvania Convention Center Philadelphia, PA|url=https://headachejournal.onlinelibrary.wiley.com/doi/abs/10.1111/head.13549|journal=Headache: The Journal of Head and Face Pain|language=en|volume=59|issue=S1|pages=1–208|doi=10.1111/head.13549|issn=1526-4610}}</ref><ref>{{Cite web|title=Aimovig users experience mixed results|url=https://www.healio.com/news/primary-care/20190710/aimovig-users-experience-mixed-results|access-date=2021-03-17|website=www.healio.com}}</ref>
 
=== See alsoNames ===
Erenumab is the [[international nonproprietary name]] and the [[United States Adopted Name]].<ref>{{cite web |title=Statement On A Nonproprietary Name Adopted By The USAN Council - Erenumab |url=https://searchusan.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Ferenumab.pdf |publisher=[[American Medical Association]] |access-date=4 November 2018 |url-status=live |archive-url=https://web.archive.org/web/20181104010146/https://searchusan.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fusan%2Ferenumab.pdf |archive-date=2018-11-04 |date=24 November 2015}}</ref><ref>{{cite journal | author = World Health Organization | author-link = World Health Organization | title = International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 115 | journal = WHO Drug Information | volume = 30 | issue = 2 | year = 2016 | url = https://www.who.int/medicines/publications/druginformation/innlists/PL115.pdf | access-date = 30 September 2022 | archive-date = 5 February 2018 | archive-url = https://web.archive.org/web/20180205073351/http://www.who.int/medicines/publications/druginformation/innlists/PL115.pdf | url-status = live }}</ref>
 
* Other anti-migraine antibodies blocking the [[calcitonin gene-related peptide]] (CGRP) pathway:
** [[Eptinezumab]]
** [[Fremanezumab]]
** [[Galcanezumab]]
 
== References ==
{{Reflist}}
 
== External links ==
* {{cite web| url = https://druginfo.nlm.nih.gov/drugportal/name/erenumab | publisher = U.S. National Library of Medicine| work = Drug Information Portal| title = Erenumab }}
 
{{Triptans}}
{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}}
{{portalPortal bar | Medicine}}▼
{{Protein and peptide receptor modulators}}
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[[Category:Antimigraine drugs]]
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[[Category:Monoclonal antibodies]]
[[Category:Amgen]]
[[Category:NovartisDrugs brandsdeveloped by Novartis]]
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