Eptinezumab

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]

Eptinezumab

Monoclonal antibody
Type	Whole antibody
Source	Humanized
Target	CALCA, CALCB
Clinical data
Trade names	Vyepti
Other names	ALD403,[1] eptinezumab-jjmr
AHFS/Drugs.com	Monograph
MedlinePlus	a620022
License data	US DailyMed: Eptinezumab
Pregnancy category	AU: B1[2]
Routes of administration	Intravenous
Drug class	Calcitonin gene-related peptide antagonist
ATC code	N02CD05 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[2][3] CA: ℞-only / Schedule D[4][5] US: ℞-only[6] EU: Rx-only[7]
Identifiers
CAS Number	1644539-04-7
DrugBank	DB14040
ChemSpider	none
UNII	8202AY8I7H
KEGG	D11303
Chemical and physical data
Formula	C6352H9838N1694O1992S46
Molar mass	143283.20 g·mol−1

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

Legal status

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. "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. "Vyepti- eptinezumab-jjmr injection". DailyMed. Archived from the original on 28 September 2021. Retrieved 27 September 2021.
7. "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. "Drug Approval Package: Vyepti". U.S. Food and Drug Administration (FDA). 23 March 2020. Retrieved 5 November 2024.
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. This article incorporates text from this source, which is in the public domain.
11. "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.

External links

• Clinical trial number NCT02559895 for "A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)" at ClinicalTrials.gov
• Clinical trial number NCT02974153 for "Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)" at ClinicalTrials.gov