Aimovig (erenumab-aooe) is the new drug that is given by once-monthly self-injections for the preventive treatment of a migraine in adults.It is the latest drug for a migraine which has received approval of U.S. Food and Drug Administration.It belongs to a new class of drugs that work by blocking the activity of calcitonin gene-related peptide(CGRP), a molecule that is involved in migraine attacks. Aimovig is a monoclonal antibody given as a shot for people who have four or more migraine days each month.
The disease is three times more common in women than in men and affects more than 10 percent of people worldwide. It can cause severe throbbing pain or a pulsing sensation, usually on just one side of the head. It is often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The pain may continue for hours to days and can be so severe that the pain hampers the daily working of life. Certain warning symptoms known as aura may occur before or with a headache. These can include flashes of light, blind spots, or tingling on one side of the face or in your arm or leg.
The effectiveness of Aimovig that aims to combat severe pain was evaluated in three clinical trials.
The first study included 955 participants with a history of an 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 an 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 a chronic migraine and compared Aimovig to placebo.
The studies have a common finding that patients on average had one to 2 ½ fewer monthly migraine days either over six months or three months.
The most common adverse effects of the drug reported by the trial participants were injection site reactions like pain and redness where you get the shot and constipation.
“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., 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.”
In addition to erenumab, three other anti-CGRP antibody treatments are competing with each other in the market which includes fremanezumab (Teva Pharmaceuticals) , galcanezumab (Eli Lilly and Co), which are currently under review and Alder BioPharmaceuticals, the manufacturer of eptinezumab is expected to file for FDA approval by the end of this year.