Advertisement

Drugs

pp 1–5 | Cite as

Erenumab: First Global Approval

AdisInsight Report
  • 234 Downloads

Abstract

Amgen and Novartis are developing erenumab (AIMOVIG™, erenumab-aooe)—a fully human monoclonal antibody calcitonin gene-related peptide (CGRP) receptor antagonist—for the prevention of migraine. CGRP is a vasodilatory neuropeptide implicated in the pathophysiology of migraine and treatment with erenumab was associated with significant reductions in migraine frequency in phase II and III clinical trials. Based on these positive results erenumab was recently approved in the US for the preventive treatment of migraine in adults and has received a positive opinion in the EU for the prophylaxis of migraines in adults who have at least 4 migraine days per month. This article summarizes the milestones in the development of erenumab leading to this first approval.

Notes

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

References

  1. 1.
    Amgen Inc. Erenumab (Aimovig™): US prescribing information. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf. Accessed 8 June 2018.
  2. 2.
    European Medicines Agency. Summary of opinion (initial authorisation): Aimovig (erenumab). 2018. http://www.ema.europa.eu. Accessed 8 June 2018.
  3. 3.
    Amgen Inc. Amgen enters into neuroscience collaboration with Novartis for Alzheimer’s disease and migraine programs [media release]. 2015. http://www.amgen.com. Accessed 1 Sep 2015
  4. 4.
    Amgen Inc. Amgen announces expanded commercial collaboration with novartis for erenumab in migraine [media release]. 2017. http://www.amgen.com. Accessed 24 Apr 2017
  5. 5.
    Shi L, Lehto SG, Zhu DX, et al. Pharmacologic characterization of AMG 334, a potent and selective human monoclonal antibody against the calcitonin gene-related peptide receptor. J Pharmacol Exp Ther. 2016;356(1):223–31.CrossRefPubMedGoogle Scholar
  6. 6.
    de Hoon J, Van Hecken A, Vandermeulen C, et al. Phase I, randomized, double-blind, placebo-controlled, single-dose, and multiple-dose studies of erenumab in healthy subjects and patients With migraine. Clin Pharmacol Ther. 2018;103(5):815–25.CrossRefPubMedGoogle Scholar
  7. 7.
    Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–37.CrossRefPubMedGoogle Scholar
  8. 8.
    Goadsby PJ, Reuter U, Hallstrom Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123–32.CrossRefPubMedGoogle Scholar
  9. 9.
    Reuter U, Goadsby P, Lanteri-Minet M, et al. Efficacy and safety of erenumab in episodic migraine patients with 2–4 prior preventive treatment failures: results from the Phase 3b LIBERTY study [abstract no. 009]. In: American Academy of Neurology 70th Annual Meeting. 2018.Google Scholar
  10. 10.
    Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425–34.CrossRefPubMedGoogle Scholar
  11. 11.
    Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382–90.CrossRefPubMedGoogle Scholar
  12. 12.
    Ashina M, Dodick D, Goadsby PJ, et al. Erenumab (AMG 334) in episodic migraine: interim analysis of an ongoing open-label study. Neurology. 2017;89(12):1237–43.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations