People who suffer from regular migraines know that they are anything but “just” headaches. They are intense, painful and debilitating. And so far, prevention options have been limited; the only FDA-approved drugs on the market for migraine prevention are actually primarily used to treat other conditions, such as high blood pressure and seizures.
That’s changing, however, as the Food and Drug Administration has approved the first new drug designed explicitly for migraine prevention. It’s called Aimovig and is made by the pharmaceutical companies Amgen and Novartis; three competitors are developing similar drugs that will be released soon.
Neurologist and headache expert Gary W. Jay, MD, clinical professor of neurology at the UNC School of Medicine, says he sees hundreds of patients who struggle with migraines, many of them several times a month. He answers our questions about Aimovig.
Why is the approval of this new drug significant?
This is the first time in more than two decades that there’s been a new medication; this is a paradigm shift. Triptans came along in the late ’80s, early ’90s, and this is the first time there’s been a new type of drug to help migraine patients since that time.
Are the current migraine drugs effective?
It depends on the patients. Currently there are four FDA-approved migraine prophylactic medications, meaning they are taken to prevent migraines. One of them can’t be prescribed to women of childbearing age because of potential birth defects. So women, who have the majority of migraines, only have three drugs that are FDA-approved.
What do we know about this new drug?
Aimovig is a monthly injection. They did three trials and found people had about one or two fewer migraine episodes a month. For many people, this is what you see with Botox injections (another sometimes-used migraine treatment). But what’s important is that even if you only lose one or two migraines a month, that’s significant for many patients who can’t even get out of bed when they have an episode. They can’t go to work. Some people experience postdromes, (symptoms after the migraine ends), where they feel like they got run over by a truck. Even if you’re only decreasing the headaches by one, maybe two, a month, you’re saving the patient suffering and time away from work and family. That patient doesn’t have to be in bed for three days.
How does Aimovig work on migraines?
What causes a migraine is very complicated, but what we do know is that a part of the trigeminal nerve in the brain appears to be the migraine generator. You see a lot of a molecule called calcitonin gene-related peptide, or CGRP, made in that area. Aimovig blocks CGRP from inhabiting its receptor in the brain. By preventing the CGRP from associating with its receptor, you may prevent the migraine.
Are there any known drawbacks to the new drug?
It’s going to cost about $7,000 a year. We don’t have any idea of what insurance will cover. Most likely, it will be financially difficult for some people, but this depends on their insurance benefits. Also, it’s given by the patient in a monthly self-injection. For patients who are needle-phobic or don’t want to inject themselves, this probably won’t be a good drug for them.
Do you have concerns about the drug?
Some. It’s a new drug, tested on maybe 2,400 people, and all those people were selected by very rigorous criteria. So many doctors will wait until it’s on the market, and 50,000 or 100,000 people have used it, to see what side effects may occur. I know Amgen and Novartis have done their work to make sure it’s as safe as possible. But patients with migraine are all very different. We need to see what happens in the real world.
Are you going to prescribe the drug?
It depends on the patient, and how much I believe the patient will follow my directions. I’ll monitor those patients closely and continue to peruse the journals and see what other doctors are seeing. I don’t have the ability to prescribe the drug quite yet; Amgen has been in contact with my office and we’ll go through the process of finding out what various insurances will cover and all that. I imagine it will be available in the next couple of weeks.
Struggling with headaches? Find a doctor near you who can help.