Eptinezumab

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Eptinezumab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target CALCA, CALCB
Clinical data
Trade names Vyepti
Other namesALD403, [1] eptinezumab-jjmr
AHFS/Drugs.com Monograph
MedlinePlus a620022
License data
Pregnancy
category
Routes of
administration 		Intravenous
Drug class Calcitonin gene-related peptide antagonist
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
Formula C6352H9838N1694O1992S46
Molar mass 143283.20 g·mol−1

Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. [6] It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. [6] [8] It is administered by intravenous infusion. [6]

Contents

Eptinezumab was approved for medical use in the United States in February 2020, [9] [10] and in the European Union in January 2022. [7] [11]

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. [6]

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. [10] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and the European Union. [10] 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. [10] The trials had similar designs. [10]

Trial 1 enrolled participants with a history of episodic migraine headaches and Trial 2 enrolled participants with chronic migraine headaches. [10] 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. [10] Neither the participants nor the health care providers knew which treatment was being given until the trial was completed. [10] 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. [10]

Society and culture

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

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. [7] The applicant for this medicinal product is H. Lundbeck A/S. [7] Eptinezumab was approved for medical use in the European Union in January 2022. [7] [11]

Names

Eptinezumab is the international nonproprietary name. [12]

It is sold under the brand name Vyepti. [6] [7]

References

  1. ↑ "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine" (Press release). Alder Biopharmaceuticals. 28 November 2016. Archived from the original on 9 August 2017. Retrieved 28 December 2016.
  2. 1 2 "Vyepti". Therapeutic Goods Administration (TGA). 24 June 2021. Archived from the original on 6 September 2021. Retrieved 6 September 2021.
  3. ↑ "AusPAR: Eptinezumab". Therapeutic Goods Administration (TGA). 3 March 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
  4. ↑ "Summary Basis of Decision (SBD) for Vyepti". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  5. ↑ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada . 3 August 2022. Retrieved 25 March 2024.
  6. 1 2 3 4 5 6 "Vyepti- eptinezumab-jjmr injection". DailyMed. Archived from the original on 28 September 2021. Retrieved 27 September 2021.
  7. 1 2 3 4 5 6 "Vyepti EPAR". European Medicines Agency (EMA). 11 November 2021. Archived from the original on 8 June 2022. Retrieved 8 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ↑ Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, et al. (November 2014). "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. doi:10.1016/S1474-4422(14)70209-1. PMID   25297013. S2CID   206161999.{{cite journal}}: CS1 maint: overridden setting (link)
  9. 1 2 "Drug Approval Package: Vyepti". U.S. Food and Drug Administration (FDA). 23 March 2020. Archived from the original on 28 October 2020. Retrieved 5 November 2024.
  10. 1 2 3 4 5 6 7 8 9 10 "Drug Trials Snapshots: Vyepti". U.S. Food and Drug Administration (FDA). 21 February 2020. Archived from the original on 30 September 2020. Retrieved 17 March 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. 1 2 "Vyepti Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  12. ↑ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl: 10665/330984 .
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