Eptinezumab, sold under the brand name Vyepti, is a
medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...
used for the preventive treatment of
migraine in adults.
It is a monoclonal antibody that targets
calcitonin gene-related peptide
Calcitonin gene-related peptide (CGRP) is a member of the calcitonin family of peptides consisting of calcitonin, amylin, adrenomedullin, adrenomedullin 2 ( intermedin) and calcitonin‑receptor‑stimulating peptide. Calcitonin is mainly produ ...
s (CGRP) alpha and beta.
It is administered by intravenous infusion.
Eptinezumab was approved for medical use in the United States in February 2020.
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History
The U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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.
Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.
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.
The trials had similar designs.
Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.
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.
Neither the subjects nor the health care providers knew which treatment was being given until the trial was completed.
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.
Society and culture
Legal status
In November 2021, the
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regardin ...
(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.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] The applicant for this medicinal product is H. Lundbeck A/S.
Eptinezumab was approved for medical use in the European Union in January 2022.
References
External links
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Antimigraine drugs
Experimental drugs
Monoclonal antibodies
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