FDA Approves First-in-Class Medicine for Migraine Prevention

Posted by The Evidence Blog on June 14, 2018

The FDA has approved Aimovig (erenumab-aooe; Amgen and Novartis) for the preventive treatment of migraine in adults. Aimovig is an injectable calcitonin gene-related peptide (CGRP) antagonist.

Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of CGRP, a molecule that is involved in migraine attacks. Other drugs in this class are still in late-stage development. “Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”

According to research by the Migraine Research Foundation, migraines affect 1 in 4 U.S. households and are considered to be the third most prevalent illness in the world. Migraine headaches were also named the sixth most disabling illness in the world.  More than 90% of people in the work force who suffer from migraines are unable to work or function during their migraine headaches.

The FDA noted in a press announcement that “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 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 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 average, 2 ½ fewer monthly migraine days than those receiving placebo.”

Patient using Aimovig will be able to self-administer monthly using Amgen's SureClick autoinjector.

A Hayes Technology Prognosis Overview on Aimovig is available here. 

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