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.
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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.