Erenumab: First Global Approval

@article{Markham2018ErenumabFG,
  title={Erenumab: First Global Approval},
  author={Anthony Markham},
  journal={Drugs},
  year={2018},
  volume={78},
  pages={1157-1161}
}
  • A. Markham
  • Published 1 July 2018
  • Medicine, Biology
  • Drugs
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… 

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References

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A Controlled Trial of Erenumab for Episodic Migraine

Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine–specific medication over a period of 6 months.

Erenumab (AMG 334) in episodic migraine

This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life and safety.

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This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life and supports further investigation of erenUMab as a preventive treatment in patients with EM.

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The results indicate that the PK profile of erenumab is nonlinear from 1 mg to 70 mg and the linear portion of the clearance from 70 mg to 210 mg is consistent with other human immunoglobulin G2 antibodies.

Pharmacologic Characterization of AMG 334, a Potent and Selective Human Monoclonal Antibody against the Calcitonin Gene-Related Peptide Receptor

Results indicate AMG 334 is a potent, selective, full antagonist of the CGRP receptor and show in vivo dose-dependent target coverage in cynos, currently in clinical development for the prevention of migraine.

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  • American Academy of Neurology 70th Annual Meeting
  • 2018

ARISE: A Phase 3 randomized trial of erenumab for episodic migraine

As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use.

Erenumab (Aimovig™): US prescribing information