Eptinezumab

Eptinezumab
Monoclonal antibody
Type	Whole antibody
Source	Humanized
Target	CALCA, CALCB
Clinical data
Trade names	Vyepti
Other names	ALD403, eptinezumab-jjmr
AHFS/Drugs.com	Monograph
License data	US DailyMed: Eptinezumab;
Pregnancy; category	AU: B1; ;
Routes of; administration	Intravenous
Drug class	Calcitonin gene-related peptide antagonist
ATC code	N02CD05 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only) ; US: ℞-only ;
Identifiers
CAS Number	1644539-04-7;
DrugBank	DB14040;
ChemSpider	none;
UNII	8202AY8I7H;
KEGG	D11303;
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.^[3] It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta.^[3]^[4]^[5] It is administered by intravenous infusion.^[3]

Eptinezumab was approved for medical use in the United States in February 2020.^[6]^[7]

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.^[7] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.^[7]

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.^[7] The trials had similar designs.^[7]

Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.^[7] 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.^[7] Neither the subjects nor the health care providers knew which treatment was being given until the trial was completed.^[7]

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.^[7]

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.^[8] The applicant for this medicinal product is H. Lundbeck A/S.^[8]

References[]

^ "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine". Alder Biopharmaceuticals. 28 November 2016.
^ ^a ^b "Vyepti". Therapeutic Goods Administration (TGA). 24 June 2021. Retrieved 6 September 2021.
^ ^a ^b ^c ^d "Vyepti- eptinezumab-jjmr injection". DailyMed. Retrieved 27 September 2021.
^ Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, et al. (November 2014). "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. doi:10.1016/S1474-4422(14)70209-1. PMID 25297013. S2CID 206161999.
^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. WHO. 31 (1). 2017.
^ "Vyepti: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 February 2020.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ "Drug Trials Snapshots: VYEPTI". U.S. Food and Drug Administration (FDA). 21 February 2020. Retrieved 17 March 2020. This article incorporates text from this source, which is in the public domain.
^ ^a ^b "Vyepti: Pending EC decision". European Medicines Agency. Retrieved 12 November 2021.