The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly 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.
"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."
Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area 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.
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.
The most common side effects that patients in the clinical trials reported were injection site reactions and constipation.
The FDA granted the approval of Aimovig to Amgen Inc.
My migraines started slow: They were infrequent but very severe in my late 20s and early 30s. After I had chemotherapy and radiation for colon cancer treatment, they became so much more severe. The radiation therapy put me into early menopause. At that point, they became so frequent that I was taking about 12 migraine abortive pills every month.
They would knock the headache back, but even a tamped-down migraine is not so much fun. It’s an all-body thing. It’s not just nausea; it’s a mental stupidity of a really shocking nature. It makes you super slow, like you’re trying to swim through molasses. Everything ordinary is just very, very hard. I was also very sensitive to light. You really just want to put a blanket over your head and lock yourself in a dark room.
It was affecting my attendance at work. I would go in late and I would be propped up at my desk. It’s so sad to think of all the things that I missed — all the times I had to call in sick, and all the fun things I missed. I missed Bruce Springsteen at Fenway Park because I had a migraine. I heard it was really good!
I tried pretty much everything to prevent migraines — antidepressants, blood pressure pills, anti-seizure pills — some of which had pretty nasty side effects. I had to stop drinking alcohol for over 10 years, because every time I drank it would trigger a headache. I tried eliminating all kinds of things: chocolate, cheeses, Diet Coke, milk. Not enough sleep can give you a headache. Travel can give you a headache, because it combines stress and not enough sleep. It’s really, really hard to control those kinds of factors. No matter what I did, I would get a headache.
I had started subscribing to the National Headache Foundation newsletters, and they sent me an email about this clinical trial. I thought, “Gosh, I have nothing to lose.” So I signed up. That was almost four years ago, and I haven’t had a migraine in over a year.
Once they doubled the dose of the shot, which they did midway through the study, that was when the headaches went to zero. I had zero side effects, which has really been remarkable, especially considering all the preventive things I tried and the side effects that they have. I haven’t renewed my prescription for that abortive headache medication in a year. I used to carry those things in my purse, and I had one in my suitcase. I was always ready in case a headache would strike. Now I’m just skipping around.