We migraineurs have waited so long for this moment — for some of us, our whole lives. For me, since I was 16. It’s a moment to celebrate. So what’s happening?
As of May 2018, the Food and Drug Administration has approved the first ever treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which has “long been postulated to play an integral role in the pathophysiology of migraine,” according to an article published in Headache.
The drug is called Aimovig (erenumab-aooe). It’s made in partnership by Amgen and Novartis Pharmaceuticals. It’s been studied in more than 3,000 patients across four global, randomized, double-blind, placebo-controlled studies that have assessed the efficacy, tolerability, and safety of the drug. This novel treatment could shake things up in the migraine treatment world. Now we have the option of a drug specifically designed for the prevention of migraines in those of us with migraine attacks four or more days a month.
In phase 2 and 3 studies in both chronic and episodic migraine, the drug was shown to reduce monthly migraine days as well as reduce acute migraine medications needed in comparison to placebo.
“These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month),” the company announced in a press release.
A phase 3b, multicenter, randomized 12-week trial looking at 246 patients from a tough-to-treat population (those with episodic migraine who had failed two to four prior treatments) called LIBERTY found that “patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.”
What this means
Can you imagine? A way to help prevent half — or more — of your migraines from happening.
I can. As an episodic migraineur with aura, I grew up knowing there was no drug to prevent migraines by watching my dad experience terrifying migraine attacks he couldn’t stop. So many of us have tried multiple treatments (me: drugs, acupuncture, chiropractic work, to name a few), none of which were developed to prevent migraines, to try to keep the pain away. We might be able to stop the pain once it had started, but we couldn’t prevent it from happening in the first place — a fact that has frustrated me to no end.
Even our beloved triptans were designed to treat migraines, not prevent them.
And each time that all-too-familiar blur starts in my left eye, followed by streamers and visual loss and pain (oh the pain!), I panic, wondering: Will this be the one time my triptan doesn’t stop the migraine? It’s such a visceral fear.
About the drug
Here’s how Aimovig works: You give yourself the drug once monthly in 70 mg or 140 mg doses through Amgen’s preloaded device, called the SureClick autoinjector.
“Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success,” Stewart J. Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth Medical School, Hanover, New Hampshire, says in the release. “Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy — with a discontinuation rate of two percent due to adverse events — and experienced sustained migraine prevention.”
According to GoodRx, the drug is not yet available in pharmacies as of June 1, 2018, which apparently can be common with the release of a new drug. Amgen said it should be available soon.
When it is available, the list price will be $575 for the once-monthly 70 or 140 mg single-use prefilled SureClick autoinjector(s), totaling $6,900 annually. The Aimovig Copay Program might help reduce a patient’s out-of-pocket cost to $5 per month for those with commercial insurance who are eligible.
To compare, Imitrex’s (sumatriptan) average retail price is $121.
What should you be concerned about?
According to the press release on the drug, the most common adverse reactions were injection site reactions and constipation.
The drug is not indicated in those who are allergic to rubber or latex, and those who are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
Will I be using it?
The short answer: No. Not right now. I had a baby in late 2017 and am not yet altering my neurologist’s plan for my postpartum migraine treatment. Might I consider it? I’ll have to discuss with my neurologist, so I can’t say. I can say that I’m happy the migraine community is receiving real advancement in research and drug development with this medication’s entrance into the marketplace.