On May 17, 2018, the United States Food and Drug Administration (USFDA) has approved Aimovig (erenumabaooe) for preventive treatment of migraine in adults1. The treatment is given by once-a-month self-injections. Aimovig is the first FDA-approved preventive migraine treatment in 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 effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials:
- The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo. Over the course of six months, Aimovig-treated patients experienced, on an average, one to two fewer monthly migraine days than those on placebo.
- The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo. Over the course of three months, Aimovig-treated patients experienced, on an average, one fewer migraine day per month than those on placebo.
- The third study evaluated 667 patients with a history of chronic migraine and compared Aimovig to placebo. In that study, over the course of three months, patients treated with Aimovig experienced, on an average, 2 ½ fewer monthly migraine days than those receiving placebo.
The FDA granted the approval of Aimovig to Amgen Inc.
About Migraine
Migraine headache is an intense pulsing or throbbing pain in one side of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by an aura – transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.
About Aimovig" (erenumab-aooe)
Aimovig is a calcitonin gene-related peptide receptor antagonist indicated to prevent migraine by blocking the CGRP-R, which is associated with migraine. Aimovig has been studied in several large global, randomized, doubleblind, placebo-controlled studies to assess its efficacy and safety in migraine prevention. More than 3,000 patients have participated in the Aimovig clinical program across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions2.
Footnotes
1 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm
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