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FDA approves first-in-class medication to prevent migraine

by Mary McNitt | May 22, 2018

The U.S. Food and Drug Administration (FDA) approved the first medication in a new class to prevent chronic migraine in adults. Aimovig™ (erenumab-aooe) will be marketed by Amgen Inc. as a self-administered, once monthly, subcutaneous (under the skin) injection. Aimovig works by blocking the activity of a molecule directly involved in migraine attacks, known as calcitonin gene-related peptide (CGRP), thus preventing migraine.

Although Aimovig represents the first in its class, it will likely not be considered a first-line therapy as there are other treatment options available to prevent migraine. It is also important to understand that medications used to prevent migraine are not the same as those used as needed to treat an acute migraine attack. Medications that prevent migraine should be used on a consistent basis in order to be effective and reduce the number of migraine attacks. Like many other chronic conditions, treatment for migraine must be individualized and based on effectiveness, side effects, and other medical conditions.

In three clinical trials evaluating effectiveness in patients who had failed several previous medications, treatment with Aimovig demonstrated a reduction in the number of days per month with migraine. Long-term safety has not yet been tested beyond fifteen months. Thus, the company plans to continue to study this medication for up to five years in duration.

Medications in this new class will likely be gaining more attention. We should expect to see other companies, such as Eli Lilly, launch similar products in the near future. Amgen has indicated the Aimovig 70 mg and 140 mg single-use auto-injector will cost around $6,900 per year, or $575 per month. In comparison, the cost for the anticonvulsant topiramate, when prescribed at the recommended dose for migraine prevention, is slightly less than $300 per month.

Amgen has indicated that Aimovig is expected to be available within one week. Prior to a full review and evaluation by our Pharmacy and Therapeutics Committee, Aimovig will require prior authorization on all of our standard formularies

To learn more about this new medication, click here or on the links below.

Sources:

  1. U.S. Food and Drug Administration. News Release. FDA approves novel preventive treatment for migraine. May 17, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm. Accessed May 18, 2018.
  2. Amgen Inc. News Releases. FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention. May 17, 2018. Available at: https://www.amgen.com/media/news-releases/2018/05/fda-approves-aimovig-erenumabaooe-a-novel-treatment-developed-specifically-for-migraine-prevention/. Accessed May 18, 2018.
  3. FiercePharma. Amgen's Aimovig won its first-in-class migraine nod. Will payers step up to the $6,900 price? May 17, 2018. Available at: https://www.fiercepharma.com/pharma/amgen-wins-blockbuster-nod-for-first-class-migraine-med-aimovig. Accessed May 18, 2018.


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