Chemistry: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 |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| Drug class | Calcitonin gene-related peptide antagonist |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| 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.[5] It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta.[5][7][8] It is administered by intravenous infusion.[5]
Eptinezumab was approved for medical use in the United States in February 2020.[9][10]
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.[10] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.[10]
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.[10] The trials had similar designs.[10]
Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.[10] 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.[10] Neither the subjects 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
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.[6] The applicant for this medicinal product is H. Lundbeck A/S.[6] Eptinezumab was approved for medical use in the European Union in January 2022.[6][11]
References
- ↑ "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine". Alder Biopharmaceuticals. November 28, 2016. http://investor.alderbio.com/releasedetail.cfm?releaseid=1001091.
- ↑ 2.0 2.1 "Vyepti". 24 June 2021. https://www.tga.gov.au/apm-summary/vyepti.
- ↑ "AusPAR: Eptinezumab". 3 March 2022. https://www.tga.gov.au/auspar/auspar-eptinezumab.
- ↑ "Summary Basis of Decision (SBD) for Vyepti". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00531&lang=en.
- ↑ 5.0 5.1 5.2 5.3 "Vyepti- eptinezumab-jjmr injection". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=79065861-6aa5-4d1f-829f-3a6471286b36.
- ↑ 6.0 6.1 6.2 6.3 "Vyepti EPAR". 11 November 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/vyepti. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "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. doi:10.1016/S1474-4422(14)70209-1. PMID 25297013.
- ↑ "International Nonproprietary Names for Pharmaceutical Substances (INN)". WHO Drug Information (WHO) 31 (1). 2017. https://www.who.int/medicines/publications/druginformation/innlists/RL77.pdf?ua=1.
- ↑ "Vyepti: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761119.
- ↑ 10.0 10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 "Drug Trials Snapshots: Vyepti". 21 February 2020. http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyepti.
This article incorporates text from this source, which is in the public domain.
- ↑ "Vyepti Product information". https://ec.europa.eu/health/documents/community-register/html/h1599.htm.
External links
- "Eptinezumab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/eptinezumab.
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