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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]
| 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 |
|
| 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 was approved for medical use in the United States in February 2020,[9][10] and in the European Union in January 2022.[7][11]
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]
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]
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]
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