Erenumab

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Erenumab
A standard 70mg/mL Aimovig autoinjector
A standard 70mg/mL Aimovig autoinjector
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetCGRPR
Names
Trade namesAimovig
Other namesAMG-334, erenumab-aooe
Clinical data
Drug classCGRPR blocker[1]
Main usesPrevent migraines[2]
Side effectsConstipation, muscle spasms[1]
Pregnancy
category
  • AU: B1[3]
  • US: N (Not classified yet)[3]
Routes of
use
Subcutaneous injection
External links
AHFS/Drugs.comMonograph
US NLMErenumab
MedlinePlusa618029
Legal
License data
Legal status
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Pharmacokinetics
Bioavailability82% (estimated)
MetabolismProteolysis
Elimination half-life28 days
Chemical and physical data
FormulaC6472H9964N1728O2018S50
Molar mass145871.98 g·mol−1

Erenumab, sold under the brand name Aimovig, is a medication used to prevent migraine headaches.[2] It is used in those who have at least 4 headaches a month.[4] It is given by injection under the skin.[2]

Common side effects include constipation and muscle spasms.[1] Other side effects may include swelling due to fluid retention.[1] While there is no evidence of harm with use in prenancy, such use has not been well studied.[5] It is a monoclonal antibody that binds to and blocks calcitonin gene-related peptide receptor (CGRPR).[1]

Erenumab was approved for medical use in the United States and Europe in 2018.[2][4] In the United Kingdom it costs about £390 every 4 weeks as of 2021.[1] This amount in the United States is about 630 USD.[6]

Medical uses

Erenumab is indicated for the prevention of migraine in adults.[7]

Dosage

It is given at a dose of 70 mg every four weeks.[1] This may be increased to 140 mg every 4 weeks.[1]

It is administered by subcutaneous injection.[8]

Side effects

Common side effects are constipation, pruritus, muscle spasms, as well as mild and mostly transient reactions at the injection site.[9]

Interactions

Erenumab was shown not to interact with ethinyl estradiol, norgestimate or the migraine drug sumatriptan. It is expected to generally have a low potential for interactions because it is not metabolized by cytochrome P450 enzymes.[9]

Pharmacology

Mechanism of action

Erenumab is a fully human monoclonal antibody blocking the calcitonin gene-related peptide receptor (CGRPR).[8][10][11]

Pharmacokinetics

After subcutaneous injection, the erenumab has an estimated bioavailability of 82%. Highest blood plasma concentrations are reached after four to six days. Like other proteins, the substance is degraded by proteolysis to small peptides and amino acids. It has an elimination half-life of 28 days.[9]

History

Development

Erenumab was developed by Amgen Inc in conjunction with Novartis.[12]

In the phase III STRIVE clinical trial 955 patients were divided into three groups in a 1:1:1 ratio. Each group was injected subcutaneously monthly with 0, 70 or 140 mg erenumab over a period of 6 months. The results were measured as mean monthly migraine days in months 4, 5, and 6. At baseline the patients experienced between 4 and 14 migraine days per month with an average of 8.3. The medication significantly reduced the number of migraine days per month by 3.2 in the 70-mg group and 3.7 in the 140-mg group, versus 1.8 in the placebo (0-mg) group.[12][13]

Approval

The United States Food and Drug Administration (FDA) approved the medication for the preventive treatment of migraine in adults on May 17, 2018. It was the first of four CGRPR antagonists to be approved that year.[7][14] The list price was reported to be US$6,900 per year.[15] It was approved for medical use in the European Union on July 26, 2018.[16][17]

In the United Kingdom, Erenumab was approved by the Scottish Medicines Consortium, but the National Institute of Health and Care Excellence rejected the drug on the basis that its cost-effectiveness was not sufficiently proven.[18][19]

See also

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 498. ISBN 978-0857114105.
  2. 2.0 2.1 2.2 2.3 "Erenumab-aooe Monograph for Professionals". Drugs.com. Retrieved 15 December 2021.
  3. 3.0 3.1 "Erenumab (Aimovig) Use During Pregnancy". Drugs.com. 17 April 2019. Retrieved 5 May 2020.
  4. 4.0 4.1 "Aimovig". Retrieved 15 December 2021.
  5. "Erenumab (Aimovig) Use During Pregnancy". Drugs.com. Retrieved 15 December 2021.
  6. "Aimovig Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 15 December 2021.
  7. 7.0 7.1 "FDA Approves First-in-Class Drug Erenumab (Aimovig) for Migraine Prevention". Medscape. 17 May 2018.
  8. 8.0 8.1 "Aimovig (erenumab-aooe) FDA Approval History". Drugs.com.
  9. 9.0 9.1 9.2 "Aimovig: EPAR - Product Information" (PDF). European Medicines Agency. 8 August 2018.
  10. "Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig (erenumab) For Migraine Patients With Multiple Treatment Failures". Drugs.com. 17 April 2018.
  11. Edvinsson L (December 2018). "CGRP Antibodies as Prophylaxis in Migraine". Cell. 175 (7): 1719. doi:10.1016/j.cell.2018.11.049. PMID 30550780.
  12. 12.0 12.1 Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, et al. (November 2017). "A Controlled Trial of Erenumab for Episodic Migraine". The New England Journal of Medicine. 377 (22): 2123–2132. doi:10.1056/NEJMoa1705848. PMID 29171821.
  13. Erenumab to prevent migraine: results from phase III STRIBE", Pharma World, December 14, 2017.
  14. "13 Things You Need to Know About Aimovig". Migraine Again. 1 February 2021. Retrieved 17 March 2021.
  15. Kolata G (17 May 2018). "F.D.A. Approves First Drug Designed to Prevent Migraines". The New York Times. ISSN 0362-4331. Retrieved 26 September 2019.
  16. "Aimovig EPAR". European Medicines Agency (EMA). Retrieved 4 May 2020.
  17. "First drug to prevent chronic migraines approved by EU". The Guardian. 31 July 2018. Retrieved 19 September 2018.
  18. Gallagher J (26 September 2019). "'Life-changing' migraine drug rejected for NHS". BBC News Online. Retrieved 26 September 2019.
  19. "New migraine drug not cost-effective NICE says in draft guidance". NICE. Retrieved 26 September 2019.

External links

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