Eptinezumab Explained

Type:mab
Mab Type:mab
Source:zu
Target:CALCA, CALCB
Tradename:Vyepti
Dailymedid:Eptinezumab
Pregnancy Au:B1
Routes Of Administration:Intravenous
Class:Calcitonin gene-related peptide antagonist
Atc Prefix:N02
Atc Suffix:CD05
Legal Au:S4
Legal Au Comment:[1] [2]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[3] [4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Cas Number:1644539-04-7
Drugbank:DB14040
Chemspiderid:none
Unii:8202AY8I7H
Kegg:D11303
Synonyms:ALD403,[6] eptinezumab-jjmr
C:6352
H:9838
N:1694
O:1992
S:46

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.[7] [8] It is administered by intravenous infusion every 3 months.

Eptinezumab was approved for medical use in the United States in February 2020.[9] [10]

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 3 months.

History

The U.S. Food and Drug Administration (FDA) approved eptinezumab based primarily on evidence from two clinical trials (Trial 1/ NCT02559895 and Trial 2/ NCT02974153) of 1741 subjects with chronic or episodic migraine headaches. Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.

The benefit and side effects of eptinezumab were evaluated in two clinical trials of adult subjects 18 – 71 years of age with a history of migraine headaches. The trials had similar designs.

Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches. Subjects 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 subjects 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

In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of a marketing authorization for the medicinal product Vyepti, intended for the prophylaxis of migraine.[11] The applicant for this medicinal product is H. Lundbeck A/S. Eptinezumab was approved for medical use in the European Union in January 2022.[12]

See also

External links

Notes and References

  1. Web site: Vyepti . Therapeutic Goods Administration (TGA) . 24 June 2021 . 6 September 2021 . 6 September 2021 . https://web.archive.org/web/20210906212122/https://www.tga.gov.au/apm-summary/vyepti . live .
  2. Web site: AusPAR: Eptinezumab . Therapeutic Goods Administration (TGA) . 3 March 2022 . 23 March 2022 . 24 March 2022 . https://web.archive.org/web/20220324042132/https://www.tga.gov.au/auspar/auspar-eptinezumab . live .
  3. Web site: Summary Basis of Decision (SBD) for Vyepti . Health Canada . 23 October 2014 . 29 May 2022 . 30 May 2022 . https://web.archive.org/web/20220530043908/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00531&lang=en . live .
  4. Web site: Health product highlights 2021: Annexes of products approved in 2021 . . 3 August 2022 . 25 March 2024.
  5. Web site: Vyepti- eptinezumab-jjmr injection . DailyMed . 27 September 2021 . 28 September 2021 . https://web.archive.org/web/20210928051812/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=79065861-6aa5-4d1f-829f-3a6471286b36 . live .
  6. Web site: Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine . November 28, 2016 . Alder Biopharmaceuticals . 28 December 2016 . 9 August 2017 . https://web.archive.org/web/20170809172257/http://investor.alderbio.com/releasedetail.cfm?releaseid=1001091 . live .
  7. 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 . 6 . 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 . The Lancet. Neurology . 13 . 11 . 1100–1107 . November 2014 . 25297013 . 10.1016/S1474-4422(14)70209-1 . 206161999 .
  8. International Nonproprietary Names for Pharmaceutical Substances (INN) . WHO Drug Information . 31 . 1 . 2017 . WHO .
  9. Web site: Vyepti: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 24 February 2020 . 21 September 2020 . https://web.archive.org/web/20200921060705/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761119 . live .
  10. Web site: Drug Trials Snapshots: Vyepti . U.S. Food and Drug Administration (FDA) . 21 February 2020 . 17 March 2020 . 30 September 2020 . https://web.archive.org/web/20200930000800/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyepti . live .
  11. Web site: Vyepti EPAR . European Medicines Agency (EMA) . 11 November 2021 . 8 June 2022 . 8 June 2022 . https://web.archive.org/web/20220608035615/https://www.ema.europa.eu/en/medicines/human/EPAR/vyepti . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. Web site: Vyepti Product information . Union Register of medicinal products . 3 March 2023.

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