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]
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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 |
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Routes of administration | Intravenous |
Drug class | Calcitonin gene-related peptide antagonist |
ATC code |
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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.[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]