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Erenumab

Erenumab
A standard 70mg/mL Aimovig autoinjector
A standard 70mg/mL Aimovig autoinjector
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetCGRPR
Clinical data
Trade namesAimovig
SynonymsAMG-334
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa618029
Routes of
administration
Subcutaneous injection
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability82% (estimated)
MetabolismProteolysis
Elimination half-life28 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6472H9964N1728O2018S50
Molar mass145871.98 g·mol−1

Erenumab (trade name Aimovig) is a medication which targets the calcitonin gene-related peptide receptor (CGRPR) for the prevention of migraine.[1][2][3] It was the first of the group of CGRPR antagonists to be FDA approved in 2018.[4] It is a form of monoclonal antibody therapy in which antibodies are used to block the receptors for the protein CGRP, thought to play a major role in starting migraines.[5]

Medical uses

Erenumab is approved for prevention of migraine in adults.[4]

It is administered by subcutaneous injection of 70 or 140 mg once a month.[6]

Side effects

Common side effects are constipation, pruritus, muscle spasms, as well as mild and mostly transient reactions at the injection site.[7]

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.[7]

Pharmacology

Mechanism of action

Erenumab is a fully human monoclonal antibody blocking the calcitonin gene-related peptide receptor (CGRPR).[6][8]

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.[7]

History

Development

This medication was developed by Amgen Inc in conjunction with Novartis.[3]

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.[3][9]

Approval and marketing

The United States Food and Drug Administration approved the medication for the preventive treatment of migraine in adults on May 17, 2018. The list price was reported to be US$6,900 per year.[10] It was licensed by the European Medicines Agency on July 31, 2018.[11]

In the United Kingdom, Erenumab has been approved by the Scottish Medicines Consortium, but the National Institute of Health and Care Excellence has rejected the drug on the basis that its cost-effectiveness was not sufficiently proven.[12][13]

See also

References

  1. ^ "Statement On A Nonproprietary Name Adopted By The USAN Council - Erenumab" (PDF). American Medical Association. November 24, 2015. Archived (PDF) from the original on 2018-11-04. Retrieved 4 November 2018.
  2. ^ World Health Organization (2016). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 115" (PDF). WHO Drug Information. 30 (2).
  3. ^ a b c Goadsby; et al. (2017). "A Controlled Trial of Erenumab for Episodic Migraine". N. Engl. J. Med. (377:2123–2132).
  4. ^ a b "FDA Approves First-in-Class Drug Erenumab (Aimovig) for Migraine Prevention". Medscape. May 17, 2018.
  5. ^ Edvinsson, Lars (December 2018). "CGRP Antibodies as Prophylaxis in Migraine". Cell. 175 (7): 1719. doi:10.1016/j.cell.2018.11.049.
  6. ^ a b "Aimovig (erenumab-aooe) FDA Approval History". Drugs.com.
  7. ^ a b c "Aimovig: EPAR - Product Information" (PDF). European Medicines Agency. 2018-08-08.
  8. ^ "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. April 17, 2018.
  9. ^ Erenumab to prevent migraine: results from phase III STRIBE", Pharma World, December 14, 2017.
  10. ^ Kolata, Gina (2018-05-17). "F.D.A. Approves First Drug Designed to Prevent Migraines". The New York Times. ISSN 0362-4331. Retrieved 2019-09-26.
  11. ^ "First drug to prevent chronic migraines approved by EU". The Guardian. 31 July 2018. Retrieved 19 September 2018.
  12. ^ Gallagher, James (2019-09-26). "'Life-changing' migraine drug rejected for NHS". BBC News. Retrieved 2019-09-26.
  13. ^ "New migraine drug not cost-effective NICE says in draft guidance". NICE. Retrieved 2019-09-26.