Monoclonal antibody | |
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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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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] [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]
Eptinezumab is a fully human monoclonal antibody blocking the calcitonin gene-related peptide receptor (CGRPR).
Eptinezumab is degraded after 3 months. [6]
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]
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]