Eptinezumab

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Eptinezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCALCA, CALCB
Clinical data
Trade namesVyepti
Other namesALD403,[1] eeptinezumab-jjmr
License data
Routes of
administration
IV
Drug classCalcitonin gene-related peptide antagonist
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6352H9838N1694O1992S46
Molar mass143283.20 g·mol−1

Eptinezumab, sold under the brand name Vyepti, is a medication for the preventive treatment of migraine in adults.[2] It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta.[3][4] It is administered by intravenous infusion every three months.[2]

Eeptinezumab-jjmr was approved for use in the United States in February 2020.[5][6]

History[edit]

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.[6] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.[6]

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.[6] The trials had similar designs.[6]

Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.[6] 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.[6] Neither the subjects nor the health care providers knew which treatment was being given until the trial was completed.[6]

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 3-month treatment period.[6]

See also[edit]

References[edit]

  1. ^ "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine". Alder Biopharmaceuticals. 28 November 2016.
  2. ^ a b "Vyeptitm (eptinezumab-jjmr) injection, for intravenous use" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 24 February 2020.
  3. ^ 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.
  4. ^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. WHO. 31 (1). 2017.
  5. ^ "Vyepti: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 24 February 2020.
  6. ^ 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.

External links[edit]

  • "Eptinezumab". Drug Information Portal. U.S. National Library of Medicine.