Aimovig™ (erenumab-aooe) received FDA approval for the prevention of Migraine in patients experiencing four or more Migraine days per month. Aimovig™ was developed by Amgen in collaboration with Novartis Pharma AG. In a joint press release, Amgen and Novartis stated,
People with frequent migraine may lose more than half their life to migraine. They endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease… At the center of the Amgen and Novartis neuroscience collaboration is the shared mission to fight migraine and the stereotypes and misperceptions surrounding this debilitating disease.
It’s a big day for people living with Migraine disease. For the first time in history, we have a treatment that was specifically developed to prevent Migraine attacks. Although there are over 100 medications commonly used to prevent Migraine, all were originally developed to treat other diseases. Only four of these treatments are FDA approved for Migraine prevention and only one additional is approved to treat Chronic Migraine. Finally we have a real Migraine preventive.
Our very own Migraine specialist, David Watson, MD, says,
The approval of a new therapeutic option in the fight against migraine disease is always a celebratory event. I am excited to see how we can use this new option to improve the lives of those affected. It is encouraging to see new medications with new mechanisms and new targets being developed.
What is Aimovig™?
- Aimovig™ (erenumab-aooe) is a fully-human monoclonal antibody that inhibits the receptor for calcitonin gene-related peptide (CGRP).
- It’s the only FDA-approved treatment specifically developed to block CGRP receptors.
- Aimovig™ indicated for the preventive treatment of Migraine in adults experiencing four or more Migraine days a month.
- It will be available by prescription as a once-monthly, single-use, prefilled SureClick® autoinjector that patients can self-administer at home.
- Over 3,000 patients participated in four clinical trials.
- The most common side effects were injection site reaction and constipation, occurring in ≥ three percent of patients receiving doses of Aimovig™.
- The discontinuation rate was two percent, which is very low for a clinical trial.
- A dedicated Phase 3b study (LIBERTY) in difficult-to-treat populations – those with episodic migraine who have failed two to four prior treatments – showed that patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.
- Dr. Stewart Tepper shared, “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.”
Access and Affordability
There’s been a great deal of speculation about the cost and availability of Aimovig™. While we still don’t know about insurance coverage, Amgen and Novartis are doing their part to make Aimovig™ as affordable and accessible as possible.
- Projected to be available by prescription within one week.
- List price (before insurance coverage or discounts) is $575 per month.
Perspective:- Trokendi XR list price is almost $700 according to GoodRx.com.
- Botox for Chronic Migraine is routinely billed at $2,500 or more every 90 days.
- Available in 70 mg or 140 mg doses.
- Aimovig Copay Program may reduce out-of-pocket costs to as little as $5 per month
Want to know more?
- An investor webcast will be hosted by Amgen on Friday, May 18, 2018 at 9:00 am EST. Live audio of this webcast will be simultaneously broadcast live and available to everyone for 90 days.
- Visit Aimovig.com to learn more about Aimovig Ally™ and the Aimovig Copay Program.
What’s so important about CGRP?
We could write volumes, but why do that when Migraine and Headache specialist, Peter Goadsby, MD, explains it so well.
Sources:
- FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention, Amgen. 17 May 2018.
- Lipton R, Diamond M, Tepper S. Expert Perspectives—Migraine Prevention for Highly Impacted Patients. US Neurology. 2018;14(Suppl.2):3–10,