Eptinezumab

{{Short description|Monoclonal antibody}} {{Use dmy dates|date=November 2024}} {{cs1 config |name-list-style=vanc |display-authors=6}} {{Infobox drug | type = mab | image = | width = | alt = | caption =

| mab_type = mab | source = zu | target = CALCA, CALCB

| pronounce = | tradename = Vyepti | Drugs.com = {{drugs.com|monograph|vyepti}} | MedlinePlus = a620022 | DailyMedID = Eptinezumab | pregnancy_AU = B1 | pregnancy_AU_comment = <ref name="Vyepti APM summary" /> | pregnancy_category = | routes_of_administration = Intravenous | class = Calcitonin gene-related peptide antagonist | ATC_prefix = N02 | ATC_suffix = CD05 | ATC_supplemental =

| legal_AU = S4 | legal_AU_comment = <ref name="Vyepti APM summary">{{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 }}</ref><ref>{{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 }}</ref> | legal_BR =  | legal_BR_comment = | legal_CA = Rx-only | legal_CA_comment = / Schedule D<ref>{{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 }}</ref><ref>{{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}}</ref> | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Vyepti FDA label">{{cite web | title=Vyepti- eptinezumab-jjmr injection | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=79065861-6aa5-4d1f-829f-3a6471286b36 | access-date=27 September 2021 | archive-date=28 September 2021 | archive-url=https://web.archive.org/web/20210928051812/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=79065861-6aa5-4d1f-829f-3a6471286b36 | url-status=live }}</ref> | legal_EU = Rx-only | legal_EU_comment = <ref name="Vyepti EPAR" /> | legal_UN =  | legal_UN_comment = | legal_status =

| CAS_number = 1644539-04-7 | CAS_supplemental = | PubChem = | IUPHAR_ligand = | DrugBank = DB14040 | ChemSpiderID = none | UNII = 8202AY8I7H | KEGG = D11303 | ChEBI = | ChEMBL = | NIAID_ChemDB = | PDB_ligand = | synonyms = ALD403,<ref>{{cite press release | title = Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine | date = 28 November 2016 | publisher = Alder Biopharmaceuticals | url = http://investor.alderbio.com/releasedetail.cfm?releaseid=1001091 | access-date = 28 December 2016 | archive-date = 9 August 2017 | archive-url = https://web.archive.org/web/20170809172257/http://investor.alderbio.com/releasedetail.cfm?releaseid=1001091 | url-status = dead }}</ref> eptinezumab-jjmr

| IUPAC_name = | C = 6352 | H = 9838 | N = 1694 | O = 1992 | S = 46 | SMILES = | StdInChI = | StdInChI_comment = | StdInChIKey = | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}

'''Eptinezumab''', sold under the brand name '''Vyepti''', is a medication used for the preventive treatment of migraine in adults.<ref name="Vyepti FDA label" /> It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta.<ref name="Vyepti FDA label" /><ref>{{cite journal |author1-link=David W. Dodick | 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 }}</ref> It is administered by intravenous infusion.<ref name="Vyepti FDA label" />

Eptinezumab was approved for medical use in the United States in February 2020,<ref name="FDA review">{{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 | archive-url=https://web.archive.org/web/20201028153128/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761119Orig1s000TOC.cfm | url-status=dead | archive-date=28 October 2020 | access-date=5 November 2024}}</ref><ref name="FDA snapshot">{{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=dead }} {{PD-notice}}</ref> and in the European Union in January 2022.<ref name="Vyepti EPAR" /><ref name="Vyepti PI" />

== Pharmacology == === Mechanism of action === Eptinezumab is a fully human monoclonal antibody, blocking the calcitonin gene-related peptide (CGRP) from binding its receptor.

=== Pharmacokinetics === Eptinezumab is degraded after three months.<ref name="Vyepti FDA label" />

== 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.<ref name="FDA snapshot" /> Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and the European Union.<ref name="FDA snapshot" /> 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.<ref name="FDA snapshot" /> The trials had similar designs.<ref name="FDA snapshot" />

Trial 1 enrolled participants with a history of episodic migraine headaches and Trial 2 enrolled participants with chronic migraine headaches.<ref name="FDA snapshot" /> 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.<ref name="FDA snapshot" /> Neither the participants nor the health care providers knew which treatment was being given until the trial was completed.<ref name="FDA snapshot" /> 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.<ref name="FDA snapshot" />

== Society and culture == === Legal status === Eptinezumab was approved for medical use in the United States in February 2020.<ref name="FDA review" /><ref name="FDA snapshot" />

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.<ref name="Vyepti EPAR">{{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.</ref> The applicant for this medicinal product is H. Lundbeck A/S.<ref name="Vyepti EPAR" /> Eptinezumab was approved for medical use in the European Union in January 2022.<ref name="Vyepti EPAR" /><ref name="Vyepti PI">{{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}}</ref>

=== Names === Eptinezumab is the international nonproprietary name.<ref>{{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 }}</ref>

It is sold under the brand name Vyepti.<ref name="Vyepti FDA label" /><ref name="Vyepti EPAR" />

== References == {{Reflist}}

== 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)}}

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Category:Antimigraine drugs Category:Experimental monoclonal antibodies