Eptinezumab
{{Short description|Monoclonal antibody}}
{{Use dmy dates|date=November 2024}}
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{{Infobox drug
| type = mab
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| mab_type = mab
| source = zu
| pronounce =
| tradename = Vyepti
| Drugs.com = {{drugs.com|monograph|vyepti}}
| MedlinePlus = a620022
| DailyMedID = Eptinezumab
| pregnancy_AU = B1
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| routes_of_administration = Intravenous
| class = Calcitonin gene-related peptide antagonist
| ATC_prefix = N02
| ATC_suffix = CD05
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| legal_AU = S4
| legal_AU_comment = {{cite web | title=Vyepti | website=Therapeutic Goods Administration (TGA) | date=24 June 2021 | url=https://www.tga.gov.au/apm-summary/vyepti | access-date=6 September 2021 | archive-date=6 September 2021 | archive-url=https://web.archive.org/web/20210906212122/https://www.tga.gov.au/apm-summary/vyepti | url-status=live }}{{cite web | title=AusPAR: Eptinezumab | website=Therapeutic Goods Administration (TGA) | date=3 March 2022 | url=https://www.tga.gov.au/auspar/auspar-eptinezumab | access-date=23 March 2022 | archive-date=24 March 2022 | archive-url=https://web.archive.org/web/20220324042132/https://www.tga.gov.au/auspar/auspar-eptinezumab | url-status=live }}
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| legal_CA = Rx-only
| legal_CA_comment = / Schedule D{{cite web | title=Summary Basis of Decision (SBD) for Vyepti | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00531&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530043908/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00531&lang=en | url-status=live }}{{cite web | title=Health product highlights 2021: Annexes of products approved in 2021 | website=Health Canada | date=3 August 2022 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | access-date=25 March 2024}}
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| legal_US = Rx-only
| legal_EU = Rx-only
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| CAS_number = 1644539-04-7
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| DrugBank = DB14040
| ChemSpiderID = none
| UNII = 8202AY8I7H
| KEGG = D11303
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| C = 6352 | H = 9838 | N = 1694 | O = 1992 | S = 46
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Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta.{{cite journal | vauthors = Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J | display-authors = 6 | title = Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial | journal = The Lancet. Neurology | volume = 13 | issue = 11 | pages = 1100–1107 | date = November 2014 | pmid = 25297013 | doi = 10.1016/S1474-4422(14)70209-1 | s2cid = 206161999 }} It is administered by intravenous infusion.
Eptinezumab was approved for medical use in the United States in February 2020,{{cite web | title=Drug Approval Package: Vyepti | website=U.S. Food and Drug Administration (FDA) | date=23 March 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761119Orig1s000TOC.cfm | access-date=5 November 2024}}{{cite web | title=Drug Trials Snapshots: Vyepti | website=U.S. Food and Drug Administration (FDA) | date=21 February 2020 | url=http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyepti | access-date=17 March 2020 | archive-date=30 September 2020 | archive-url=https://web.archive.org/web/20200930000800/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyepti | url-status=live }} {{PD-notice}} and in the European Union in January 2022.
Pharmacology
= Mechanism of action =
Eptinezumab is a fully human monoclonal antibody, blocking the calcitonin gene-related peptide (CGRP) from binding its receptor.
= Pharmacokinetics =
History
The US Food and Drug Administration (FDA) approved eptinezumab based primarily on evidence from two clinical trials (Trial 1/NCT02559895 and Trial 2/NCT02974153) of 1741 participants with chronic or episodic migraine headaches. Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and the European Union. The benefit and side effects of eptinezumab were evaluated in two clinical trials of adults aged 18 through 71 years of age with a history of migraine headaches. The trials had similar designs.
Trial 1 enrolled participants with a history of episodic migraine headaches and Trial 2 enrolled participants with chronic migraine headaches. Participants were assigned to receive one of two doses of eptinezumab or placebo injections every three months for a total of twelve months in Trial 1, and for a total of 6 months in Trial 2. Neither the participants nor the health care providers knew which treatment was being given until the trial was completed. The benefit of eptinezumab in comparison to placebo was assessed based on the change in the number of migraine days per month during the first three-month treatment period.
Society and culture
= Legal status =
Eptinezumab was approved for medical use in the United States in February 2020.
In November 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of a marketing authorization for the medicinal product Vyepti, intended for the prophylaxis of migraine.{{cite web | title=Vyepti EPAR | website=European Medicines Agency (EMA) | date=11 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vyepti | access-date=8 June 2022 | archive-date=8 June 2022 | archive-url=https://web.archive.org/web/20220608035615/https://www.ema.europa.eu/en/medicines/human/EPAR/vyepti | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. The applicant for this medicinal product is H. Lundbeck A/S. Eptinezumab was approved for medical use in the European Union in January 2022.{{cite web | title=Vyepti Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1599.htm | access-date=3 March 2023}}
= Names =
Eptinezumab is the international nonproprietary name.{{cite journal | vauthors = ((World Health Organization)) | year = 2017 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77 | journal = WHO Drug Information | volume = 31 | issue = 1 | hdl = 10665/330984 | hdl-access = free | author-link = World Health Organization }}
References
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External links
- {{ClinicalTrialsGov|NCT02559895|A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)}}
- {{ClinicalTrialsGov|NCT02974153|Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)}}
{{Triptans}}
{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}}
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