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Aimovig (erenumab) receives EU approval for migraine prevention

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Aimovig (erenumab) has received EU approval for the prevention of migraine in adults experiencing four or more migraine days per month. This follows recent approvals in the US, Switzerland and Australia. Aimovig remains the first and only approved treatment designed to block the CGRP receptor and can be self-administered every four weeks using the SureClick® autoinjector pen, a device commonly used in a range of conditions.

“Erenumab heralds a new era in clinical practice, bringing both a targeted mechanism for prevention and a deep understanding of migraine, which we have never had before. We will see sustained relief from migraine for many of those who suffer with this debilitating disease,” said Professor Peter Goadsby, Director of the NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College London.

In a clinical trial programme of 2,600 patients, erenumab has demonstrated significant reductions in number of migraine days per month, including in patients who failed 2-4 previous treatments commonly used for migraine prevention, with a safety and tolerability profile similar to placebo.1-5 It has also shown sustained efficacy in migraine prevention in longer term analyses over 12-15 months.6-7

References

  1. Goadsby PJ et al. Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132.
  2. Dodick DW et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037.
  3. Tepper S, Ashina M, Reuter U. Safety and efficacy of erenumab for preventive treatment of chronic migraine: A randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 2017; 16: 425–434.
  4. Reuter U 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. Emerging science abstract presented at AAN, 24 April 2018, Los Angeles.
  5. www.cgrpforum.org/liberty-full-results-confirm-erenumabs-efficacy-in-migraine-patients-unresponsive-to-previous-prophylaxis/
  6. Ashina M et al. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology. 2017 Sep 19;89(12):1237-1243.
  7. www.cgrpforum.org/erenumab-extension-studies-support-efficacy-up-to-one-year-and-safety-up-to-three-years/