Eptinezumab

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Eptinezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCALCA, CALCB
Names
Trade namesVyepti
Other namesALD403,[1] eptinezumab-jjmr
Clinical data
Drug classCalcitonin gene-related peptide antagonist
Main usesPrevention of migraines[2]
Side effectsRunny nose, allergic reactions[2]
Pregnancy
category
Routes of
use
Intravenous
Typical dose100 mg q 3 months[4]
External links
AHFS/Drugs.comMonograph
US NLMEptinezumab
Legal
License data
Legal status
Chemical and physical data
FormulaC6352H9838N1694O1992S46
Molar mass143283.20 g·mol−1

Eptinezumab, sold under the brand name Vyepti, is a medication used to prevent migraines in adults.[2] It is used in those who have at least four migraines per month.[4] It is given by gradual injection into a vein.[2]

Common side effects include runny nose and allergic reactions.[2] While there is no evidence of harm in pregnancy, such use has not been well studied.[2] It is a monoclonal antibody that blocks calcitonin gene-related peptides (CGRP).[2]

Eptinezumab was approved for medical use in the United States in 2020 and Europe and the United Kingdom in 2022.[2][4][7] In the United States it costs about 1,700 USD per dose as of 2022.[8] It is being studied in cluster headaches.[7]

Medical uses

It decreases migraines by about one to two day more per month more than a placebo in those who have frequent headaches.[4]

Dosage

It is generally started at 100 mg over 30 minutes every three month.[4] This may be increased to 300 mg if needed.[4]

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.[9] Trials were conducted at 212 sites in United States, Georgia, Russia, Ukraine and European Union.[9]

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.[9] The trials had similar designs.[9]

Trial 1 enrolled subjects with a history of episodic migraine headaches and Trial 2 enrolled subjects with chronic migraine headaches.[9] 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.[9] Neither the subjects nor the health care providers knew which treatment was being given until the trial was completed.[9]

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.[9]

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.[4] The applicant for this medicinal product is H. Lundbeck A/S.[4] Eptinezumab was approved for medical use in the European Union in January 2022.[4]

References

  1. "Alder BioPharmaceuticals Initiates PROMISE 2 Pivotal Trial of Eptinezumab for the Prevention of Migraine". Alder Biopharmaceuticals. November 28, 2016. Archived from the original on 9 August 2017. Retrieved 28 December 2016.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "Vyepti- eptinezumab-jjmr injection". DailyMed. Archived from the original on 28 September 2021. Retrieved 27 September 2021.
  3. 3.0 3.1 "Vyepti". Therapeutic Goods Administration (TGA). 24 June 2021. Archived from the original on 6 September 2021. Retrieved 6 September 2021.
  4. 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 "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.
  5. "AusPAR: Eptinezumab". Therapeutic Goods Administration (TGA). 3 March 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
  6. "Summary Basis of Decision (SBD) for Vyepti". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  7. 7.0 7.1 "Eptinezumab". SPS - Specialist Pharmacy Service. 29 June 2017. Archived from the original on 12 November 2022. Retrieved 4 November 2022.
  8. "Vyepti Prices, Coupons, Copay & Patient Assistance". Drugs.com. Archived from the original on 3 August 2021. Retrieved 4 November 2022.
  9. 9.0 9.1 9.2 9.3 9.4 9.5 9.6 9.7 "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

External sites:
Identifiers: