Eptinezumab

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Eptinezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCALCA, CALCB
Clinical data
Trade namesVyepti
Other namesALD403,[1] eptinezumab-jjmr
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration
Intravenous
Drug classCalcitonin gene-related peptide antagonist
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
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 used for the preventive treatment of migraine in adults.[5] It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta.[5][7][8] It is administered by intravenous infusion.[5]

Eptinezumab was approved for medical use in the United States in February 2020.[9][10]

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.[10] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.[10]

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.[10] The trials had similar designs.[10]

Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.[10] 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.[10] Neither the subjects 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]

Society and culture[edit]

Legal status[edit]

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.[6] The applicant for this medicinal product is H. Lundbeck A/S.[6] Eptinezumab was approved for medical use in the European Union in January 2022.[6]

References[edit]

  1. ^ "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine". Alder Biopharmaceuticals. 28 November 2016. Archived from the original on 9 August 2017. Retrieved 28 December 2016.
  2. ^ a b "Vyepti". Therapeutic Goods Administration (TGA). 24 June 2021. Archived from the original on 6 September 2021. Retrieved 6 September 2021.
  3. ^ "AusPAR: Eptinezumab". Therapeutic Goods Administration (TGA). 3 March 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
  4. ^ "Summary Basis of Decision (SBD) for Vyepti". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  5. ^ a b c d "Vyepti- eptinezumab-jjmr injection". DailyMed. Archived from the original on 28 September 2021. Retrieved 27 September 2021.
  6. ^ a b c d "Vyepti EPAR". European Medicines Agency (EMA). 11 November 2021. Archived from the original on 8 June 2022. Retrieved 8 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ 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.
  8. ^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. WHO. 31 (1). 2017.
  9. ^ "Vyepti: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 21 September 2020. Retrieved 24 February 2020.
  10. ^ a b c d e f g h i "Drug Trials Snapshots: Vyepti". U.S. Food and Drug Administration (FDA). 21 February 2020. Archived from the original on 30 September 2020. Retrieved 17 March 2020. Public Domain 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.