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Ajovy (fremanezumab) wins US approval in migraine prevention

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Ajovy (fremanezumab) has become the second anti-CGRP agent to gain approval for migraine prophylaxis in adults in the USA. It is the first and only anti-CGRP treatment with both monthly (225 mg) and quarterly (675 mg) dosing options.

“About 40% of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days,” said Professor Stephen Silberstein, Director, Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, USA, and lead investigator of the Phase III clinical trial programme for fremanezumab.

Fremanezumab was evaluated for migraine prevention in two Phase III, placebo-controlled clinical trials – one in episodic migraine and one in chronic migraine. The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

In episodic migraine, subcutaneous fremanezumab resulted in a statistically significant 1.3- to 1.5-day reduction in the mean number of monthly migraine days, compared with placebo, over a 12-week period (p<0.001 for both doses).1,2

In chronic migraine, mean reduction in headache days per month, compared to placebo, was 2.1 days with monthly fremanezumab injection and 1.8 days with fremanezumab quarterly injection, over a 12-week period (p<0.001 for both doses).3,4

Ajovy is expected to be available through retail and specialty pharmacies in the USA in early October 2018. The US Wholesale Acquisition Cost (WAC) of Ajovy is $575 per monthly dose and $1,725 per quarterly dose.

The first anti-CGRP agent to become available, Aimovig (erenumab), was approved in the US in May 20185 and in the EU in July 2018.6

References 

  1. Dodick DW, Silberstein SD, Bigal ME et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine. A randomized clinical trial. JAMA 2018;319(19):1999-2008.
  2. Phase 3 HALO data on fremanezumab in episodic migraine published in JAMA.
    https://www.cgrpforum.org/phase-3-halo-data-on-fremanezumab-in-episodic-migraine-published-in-jama/
  3. Silberstein SD, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 2017;377:2112-22.
    http://www.nejm.org/doi/full/10.1056/NEJMoa1709038
  4. Fremanezumab cuts headache frequency in chronic migraine in phase 3 study.
    https://www.cgrpforum.org/fremanezumab-cuts-headache-frequency-in-chronic-migraine-in-phase-3-study/
  5. Aimovig (erenumab) approved for migraine prevention in US adults.
    https://www.cgrpforum.org/aimovig-erenumab-approved-for-migraine-prevention-in-us-adults/
  6. Aimovig (erenumab) receives EU approval for migraine prevention.
    https://www.cgrpforum.org/aimovig-erenumab-receives-eu-approval-for-migraine-prevention/