Eptinezumab
Monoclonal antibody
- US DailyMed: Eptinezumab
category
- AU: B1[2]
administration
- N02CD05 (WHO)
- 1644539-04-7
- DB14040
- none
- 8202AY8I7H
- D11303
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][9] It is administered by intravenous infusion every 3 months.[6]
Eptinezumab was approved for medical use in the United States in February 2020.[10][11]
Pharmacology
Mechanism of action
Eptinezumab is a fully human monoclonal antibody blocking the calcitonin gene-related peptide receptor (CGRPR).
Pharmacokinetics
Eptinezumab is degraded after 3 months.[6]
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.[11] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.[11]
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.[11] The trials had similar designs.[11]
Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.[11] 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.[11] Neither the subjects nor the health care providers knew which treatment was being given until the trial was completed.[11]
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.[11]
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.[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][12]
See also
References
- ^ "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine". Alder Biopharmaceuticals. 28 November 2016. Archived from the original on 9 August 2017. Retrieved 28 December 2016.
- ^ a b "Vyepti". Therapeutic Goods Administration (TGA). 24 June 2021. Archived from the original on 6 September 2021. Retrieved 6 September 2021.
- ^ "AusPAR: Eptinezumab". Therapeutic Goods Administration (TGA). 3 March 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
- ^ "Summary Basis of Decision (SBD) for Vyepti". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
- ^ a b c d e "Vyepti- eptinezumab-jjmr injection". DailyMed. Archived from the original on 28 September 2021. Retrieved 27 September 2021.
- ^ a b c d "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.
- ^ 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.
- ^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. 31 (1). WHO. 2017.
- ^ "Vyepti: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 21 September 2020. Retrieved 24 February 2020.
- ^ a b c d e f g h i "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.
This article incorporates text from this source, which is in the public domain. - ^ "Vyepti Product information". Union Register of medicinal products. Retrieved 3 March 2023.
External links
- "Eptinezumab". Drug Information Portal. U.S. National Library of Medicine.
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Antimigraine preparations (N02C)
| Serotonergics |
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| CGRP-R antagonists | |||||||||||
| Others |
| Calcium channel blockers | |
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| Progestogens | |
| Sympatholytics | |
| Tricyclic antidepressants | |
| Anticonvulsants | |
| Anti-CGRP/CGRP-R mAbs |
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| CGRP-R antagonists |
- #WHO-EM
- ‡Withdrawn from market
- Clinical trials:
- †Phase III
- §Never to phase III
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