Aimovig: Migraine prevention

Aimovig has been approved by the FDA on May 17, 2018 as a new migraine prevention. It is taken by the patient as a once per month injection. 

Aimovig is a monthly injection with a device similar to an insulin pen. Side effects did not occur more frequently with people taking Aimovig then then with people taking a placebo pill.  Aimovig blocks the neurotransmitter CGRP.  CGRP is one of the principal chemical messengers for headache-type pain signals.  This is the first medication that works with this mechanism that the FDA has approved.  Two other similar drugs, from different pharmaceutical companies, are still pending FDA approval.

Following are some data characterizing improved migraine control associated with Aimovig:

STRIVE, an Aimovig phase 3 trial, randomized 955 patients (1:1:1) in a 24 week double-blind placebo controlled study of subcutaneous injections of Aimovig 70 mg or Aimovig 40 mg or placebo once per month for 6 months. 

Patients had average 8.7 migraines per month before entering the study.  All findings at the p< 0.001 probability level.

Primary endpoint data favoring Aimovig included:

  • Patients receiving the highest dose of Aimovig, 140 mg, reported 3.7 less migraine days per month (statistically better than the lower dose, 70 mg ((3.2 day reduction); and statistically better than placebo (1.8 day per month reduction).
  • 50% of patients on 140 mg Aimovig had less than half of the average migraine days per month across all groups in the month before starting dosing (again statistically better than both of the other groups (43.3% for Aimovig 70 mg group; 26.6% for placebo).

 

Secondary endpoint data favoring Aimovig include:

  • Patients taking erenumab had significant reductions in the number of days per month using an acute or “rescue” migraine-specific medication (1.6 days for 140mg group and 1.1 days for 70mg compared to 0.2-day reduction with placebo; both p<0.001).
  • Results from the MPFID showed erenumab delivered meaningful benefits by reducing the impact of migraine on patients’ everyday activities, such as getting ready for the day, doing household chores or activities requiring concentration (5.9 points, 140mg; 5.5 points, 70 mg; 3.3 points, placebo; both p<0.001).
  • MPFID scores in physical impairment, such as getting out of bed or activities requiring physical effort, were also significantly reduced with erenumab (4.8 points, 140mg; 4.2 points, 70 mg; 2.4 points, placebo; both p<0.001).

Aimovig will provide a new choice for migraine prevention.  The data are persuasive: It helps migraine  significantly compared to placebo (an injection that contains no medication at all).   However, it does not help everyone with migraine.  No significant side effects are found.  However, the medication has only been tested across a relatively small clinical trial population.  It has not been monitored across a large postmarketing population.

In addition, there may be some insurance issues for obtaining the medication when it does become available.  According to New York times May 17, 2018 article, the list price will be $6,900 a year.  They report that in a preliminary analysis of cost-effectiveness, I.C.E.R. (institute for clinical and economic review: an independent nonprofit organization which provides comprehensive clinical cost-effective analyses of treatments, tests and procedures) concluded that if the Amgen drug cost $8,500 a year, the price would be reasonable for the expected improvement in quality of life for patients with a migraine at least 15 times a month and no other options, said Dr. David Rind, the institute’s chief medical officer.

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