FDA Approves Preventive Migraine Treatment


Erenumab-aooe (Aimovig, Amgen) is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of the molecule that is involved in migraine attacks.

Officials with the FDA have approved erenumab-aooe (Aimovig, Amgen) for the preventive treatment of migraine in adults, making it the first approved preventive migraine treatment of its kind, according to a press release.

Erenumab-aooe is part of a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. The treatment is given by once-monthly self injections.

“Aimovig provides patients with a novel option for reducing the number of days with migraine,” Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “We need new treatments for this painful and often debilitating condition.”

Patients who experience migraines often encounter intense pulsing or throbbing pain in 1 area of the head, and have additional symptoms such as nausea or vomiting, and sensitivity to light and sound. According to the press release, migraine is 3 times more common in women than in men and affects more than 10% of people worldwide.

The approval is based on data from 3 clinical trials that evaluated the efficacy of erenumab-aooe. In the first study, 955 participants with a history of episodic migraine were enrolled to compare treatment with erenumab-aooe with a placebo over the course of a 6-month period. Patients treated with erenumab-aooe experienced 1 to 2 fewer monthly migraine days on average compared with those on placebo.

The second study included 577 patients with a history of episodic migraine over a 3-month period. In this study, patients treated with erenumab-aooe, on average, had 1 fewer migraine day per month than those on placebo.

In the third study, 667 patients with a history of chronic migraine were evaluated over the course of 3 months. Patients treated with erenumab-aooe, on average, experienced 2 ½ fewer monthly migraine days than those receiving placebo.

The most common adverse effects reported in the trial were injection site reactions, and constipation.

This article originated on SpecialityPharmacyTimes.com.

For more extensive coverage pertaining to headaches and migraines, check out Pharmacy Times' sister site, NeurologyLive. The Clinical Focus page hosts hundreds of articles and videos, as well as the most recently released information on data and research.


FDA approves novel preventive treatment for migraine [news release]. Silver Spring, MD: FDA website; May 17, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm?utm_campaign=05172018_PR_FDA%20approves%20migraine%20prevention%20treatment&utm_medium=email&utm_source=Eloqua Accessed May 18, 2018.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
Image credit: fidaolga - stock.adobe.com
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund | stock.adobe.com
Young male pharmacist giving prescription medications to senior female customer in a pharmacy | Image Credit: Zamrznuti tonovi - stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.