Aimovig Approved by FDA as First Calcitonin-Gene-Related Peptide (CGRP) Blocker for Migraine Prevention

Aimovig Approved by FDA as First Calcitonin-Gene-Related Peptide (CGRP) Blocker for Migraine Prevention

The U.S. Food and Drug Administration (FDA) has approved Aimovig as the first calcitonin-gene-related peptide (CGRP) blocker for the preventive treatment of migraine. Aimovig is a self-administered injector that is used once monthly to prevent migraine attacks in people who have migraine. The list price is $6,900 a year, which is substantially lower than anticipated pricing.1 For the millions of patients living with excruciating and debilitating migraine, the approval of Aimovig is an important therapeutic development offering new hope for relief from their unbearable symptoms.

How does Aimovig work?

CGRP is a newly identified protein that acts like a neurotransmitter (a chemical messenger) throughout the brain and body. CGRP is found in large numbers in the trigeminal system, the sensory nerves that supply the head and neck. CGRP is found in high levels during a migraine attack.

Aimovig is a monoclonal antibody that targets and neutralizes the CGRP receptors. By not allowing CGRP to connect with its receptors, it is believed that Aimovig helps stop migraine that were instigated by CGRP.1,2

How effective is Aimovig?

In clinical trials, patients receiving Aimovig experienced significant reductions in the number of migraine days per month, as well as a reduction in their use of acute treatment of migraine, compared to patients receiving placebo. In one of the latest studies, Aimovig was given to patients who have already tried 2-4 prior treatments without getting relief. Aimovig had nearly three-fold higher odds of cutting their migraine days by 50% or more compared to placebo.1

Why is this important?

Migraine is a debilitating condition, and many people with migraine do not get relief from their symptoms with the currently available therapies. These are often drugs that were originally used for other conditions like high blood pressure or epilepsy. In addition, many of the currently available treatments have significant side effects that make them unsuitable options for certain people. Aimovig offers a new treatment option for people living with migraine, and it is the first medication of its kind. Additional CGRP blockers are in development and are expected to get approval within the next year or so.

What are the possible side effects of Aimovig?

The most common side effects experienced by patients receiving Aimovig in clinical trials were injection site reactions (pain, redness) and constipation.1

Poll

View References
  1. FDA Approves Aimovig (erenumab-aooe), a Novel Treatment Developed Specifically for Migraine Prevention. Amgen press release. Available at https://www.amgen.com/media/news-releases/2018/05/fda-approves-aimovig-erenumabaooe-a-novel-treatment-developed-specifically-for-migraine-prevention/. Accessed 5/17/18.
  2. New Drug Offers Hope to Millions With Severe Migraines. New York Times. Available at https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html. Accessed 5/17/18.

Comments

View Comments (26)
  • Cuddles
    1 day ago

    I took my first shot 9 days ago. Unfortunately I was misled into believing that once you take the shot , you can start eating the foods that are your usual migraine triggers( cheese, wine, chocolates ) as the shot prevents the migraine triggers from acting. I also thought I should quickly wean myself from the high dose Corgard( beta blocker medication) that I was on that was doing a fair job in curbing my migraine attacks. On Corgard I was getting 2-3 migraine attacks a month which was the best success I’ve had. However my heart rate was low and I had a lot of fatigue . I’m a busy mum and professional. Six days later after taking Aimovig and eating what I wanted ( chocolates, wine) and off Corgard, I came down with one of worse possible migraine attacks that almost got me to the ER. Luckily I was able to control it with 2 Maxalt and Brufen. I quickly learnt that taking Aimovig does not mean you can come off your migraine free diet- you still have to watch out for food triggers. Also it’s best to wean yourself of any migraine prevention drugs you already on very slowly and carefully and if possible stay on it for a few months till Amiovig potentially kicks in. You must also realize that Amiovig is not a 100 % cure- it just reduces the frequency by 50%. There is a good chance that your current migraine prevention drugs cut your migraine frequency down by 80% which may be in my case. So these are some of the things you may have to consider when taking Amiovig and discuss with your physician.

  • MigraineBabe
    3 months ago

    I started Amovig about 3 weeks ago. I was expecting more. I still have a migraine every day but they are less intense. I am seeing a lot of 2 and 3 that used to be 5 and 6. So that’s good. I’ve only had 3 bad migraines that set me back. That’s better too. I’m worried about the third shot. What will my insurance company pay?

  • Joanna Bodner moderator
    3 months ago

    It certainly varies by company. Have you done their trial yet and/or looked into their assistance program? There has been some discussion in our forums about insurance coverage if you’d like to check it out. – https://migraine.com/forum/cgrps-calcitonin-gene-related-peptide/ Good luck & keep us posted! -Joanna (Migraine.com Team)

  • CathyinPain
    4 months ago

    Just got the first of my 2 free injections today and couldn’t wait to get it in my system. I have not had any luck with any prophylactic medication for my migraines, and I’ve gone through all of them. I’ve had chronic migraine problems since I was 14 and I just turned 60 last week. I will report my progress but I’m also trying not to get my hopes up too high. I have been disappointed too many times. Thanks for all the information.

  • Jill M.
    4 months ago

    I have just started month 2 of Aimovig. Have had very positive results so far. Only difficulty I’ve had is constipation, but Miralax and an occasional stool softener is helping with that. I only had 6 migraines last month. Usual is around 10-12. The biggest differences I noticed (in addition to a decrease in frequency) is a reduction in severity, increased response to abortives, and increased general mental clarity! Very good results!! I started at 140mg, which is the maximum dose – two injections. I was able to get the 2 free trial months of Aimovig. I just received a letter yesterday that my insurance has approved the medication. I am so excited to continue this journey – I have high hopes that it will continue to do well for me.

  • CARothermundFranklin
    4 months ago

    I await insurance approval for Aimovig with renewed hope for migraine relief! After 40 years with these unpredictable migraine attacks, many of which come on suddenly, ruin plans, outings and ultimately make life miserable, I pray this new approach to migraine management will work. I’ve tried every preventative approach available and none have proved tolerable. I even wrote and published a book about life with migraines to share the pain, frustrations and journey of how migraines define us.

  • KarenE
    6 months ago

    I just talked to my neurologist about Aimovig. He told me that unless you are one of the people whose migraines are CGRP related, Aimovig will not work. In the clinical trials, 30% of the test subjects experienced 40% fewer migraines per month compared to those who took placebo. So the Aimovig worked for roughly 1/3 of the people, and eliminated 3-4 migraines per month.

    The article says Aimovig will cost about $6,900/year. For those of us whose insurance companies won’t pay for new, expensive drugs, that means $575/month for a 30% chance that I’ll have 3 or 4 fewer migraines per month. I’m on Social Security disability (fixed income) due to migraines, and I can’t afford to spend my money on drugs that have such low odds of helping.

    On a more positive note, my neurologist said other manufacturers’ versions of Aimofig will be available in a few months, so the price should drop significantly and insurance companies will be more likely to pay a portion of the cost.

  • Joanna Bodner moderator
    6 months ago

    Hey there Karen,
    I would strongly encourage you to look into Aimovig’s support program. We have heard some great feedback about the ease of use for the program and that they are providing generous assistance. Here is the link in case you have not already explored. – https://www.aimovig.com/co-pay-and-support/ Thanks for taking the time to share some info with us!

  • Cappucinno
    6 months ago

    In the recent past, I have heard snippets of information about a new drug coming soon that would be a preventive drug. I guess Aimovig is the drug they were referring to. Yay that it is here, but not at the price that it could cost. I also have Medicare and a Secondary Ins. coverage so I don’t know where I will fit in coverage wise. I have also had migraines for about 35 years. I am now seeing 2 Neurologists. One is my doctor for about 22 years who prescribes my meds and my other one administers Botox and also a nerve block in my occipital nerve. I have had 3 Botox injections since Nov. and 1 nerve block about a month ago and I have not had any relief except for little moments here and there. The only thing that helps is my 100 mg. Imitrex along with a 2 mg. Valium (for minor palps) and that is not always and not for all day.At least it is something!!

  • brandtizzle
    6 months ago

    I am receiving my first two doses FREE via fedex tomorrow. My dr knew about aimovig months ago and started prescribing last week. Aimovig’s drug company had a simple form to fill out and I was assigned a case manager who called and explained the process. They are giving a free trial while they work with insurance companies to establish how patients get it covered. They also have another service you can apply for if your insurance won’t cover it. The drug company had a specialty pharmacy contact me and explain when it would arrive. I was expecting delays, red tape, and expense, but this has been the smoothest process. I’ve suffered with chronic intractible migraines for 35 years. To say I’m excited would be an understatement.

  • emilydownward author
    6 months ago

    Thanks for sharing your experience with the free trial process, brandtizzle! I’m excited for you, too, and hope you finally find some relief. Take care, Emily (Migraine.com Team)

  • mrst53
    7 months ago

    I think the price is outrageous. There are a lot of us who are on Medicare and there is no mention of Medicare taking care of part of this price. I would love to try it, but not at this price. $575 an injection. Wow…

  • Trish
    7 months ago

    From what I read on their website, people on Medicare are specifically excluded from their product support program.

  • Joanna Bodner moderator
    7 months ago

    We have heard some encouraging feedback regarding their product support program. Here is the information on it if you’d like to explore – https://www.aimovig.com/co-pay-and-support. Sure hope you will have the ability to try it! Thanks for the comment. Take good care. Joanna (Migraine.com Team)

  • nikkig127
    7 months ago

    Even with the same results, I’d much rather one injection a month than having to:

    – Take the 6 pills a day I take now
    – Remember to pick up refills at different times every month
    – Go through with withdrawals when I forget to pick up refills
    – Have to worry about getting in touch with my doctor and pharmacy every time a refill runs out
    – Have to worry about packing the right number of pills every time I travel
    – Have to worry about the weight gain that comes with the amitriptyline
    – Have to worry about the being a zombie that comes with topamax
    – Have to worry about the stomach issues that comes with magnesium

    Basically, one injection a month, even if it’s just to get the same results, the path to get those same results make way more sense than what we’re doing now. So, I’m definitely going to talk to my doctor about this!

  • Jess08
    7 months ago

    I made an appointment with my neurologist as soon as I found out it was approved. I have been waiting for this to be available for over a year. I know my Doctor will prescribe it, Im just worried about the cost as I have terrible insurance! My appointment is 6 days away and I am anxiously waiting to give this a try as I have been suffering from migraines for over 15 years and have not found any relief in any preventative drugs as of yet.

  • Joanna Bodner moderator
    7 months ago

    I sure am sending you much support & hope that this treatment will provide you with the relief you have been LONG awaiting for! I certainly realize cost is a big factor for you & for so many, so in case you were not aware, they are offering a product support program which you can read more about here. – https://www.aimovig.com/co-pay-and-support

    Will you keep us posted on this journey?
    Wishing you a gentle day.
    Best,
    Joanna (Migraine.com Team)

  • Marikay62
    7 months ago

    I called the company as my Dr will write a script for it. They are sending a form for myself and my Dr. to fill out. They will do all the insurance checking for you. You will get your 1st 2 injections free, and then only have a $5 copay after that. You do have to have commercial insurance. Call the company before your Dr appt.
    ‭(833) 246-6844‬

  • Patrick
    7 months ago

    It’s really depressing to me that this is so completely unaffordable for patients barely surviving on federal disability income alone (no family/spousal financial support). Great treatment for those still able to work or getting outside financial support, while it leaves those of us suffering and affected the most to suffer daily, unable to return to any semblance of a normal working life.

  • Jill M.
    4 months ago

    If you are interested in Aimovig, please visit their website. There are programs available to help with the cost – copay program, Bridge program. If you begin with the 2 month free trial, you will be assigned a case manager who will help you along the journey. Amogen, the manufacturer, has been nothing but helpful to me in this journey.

  • Joanna Bodner moderator
    4 months ago

    Great tip & thanks for sharing this with the community! They certainly are trying to make it as cost effective as possible! SO awesome to hear you have already begun to experience good results. May it continue! Will you keep us posted on your progress if you can? -Joanna (Migraine.com Team)

  • Joanna Bodner moderator
    7 months ago

    Hi there Patrick,
    We sure here you regarding the major concern regarding cost. I noticed that @marikay62 left a helpful comment & tip regarding above as it sounds like they have done some investigating. Here is some information on the product support program they are offering.https://www.aimovig.com/co-pay-and-support. It sounds like the company is really trying to keep costs down and sure hope that is case & that many will gain the access to these treatments! Thanks for taking the time to comment today. Best, Joanna (Migraine.com Team)

  • C.Zelaya
    7 months ago

    I was reading the nearly 200 page clinical studies report that just came out. Now, I’m no expert in understanding some of this, but if I’m reading this right, it looks like 1. They didn’t include people in the studies if they had previously failed to show improvements or response to two other categories of preventive therapies. And 2. The results are no better and no worse than topiramate, amitriptyline or propranolol. Am I understanding this right?

  • emilydownward author
    7 months ago

    Hi C.Zelaya, I believe the last study conducted before filing with the FDA did include people who had failed to have improvement with other preventive therapies. I don’t think there have been any head-to-head studies comparing Aimovig to other medications. The studies that have been done which are referenced here compared Aimovig to placebo. Hope that helps! Best, Emily (Migraine.com Team)

  • Soteria
    7 months ago

    Having been fortunate enough to be part of the clinical trials for this antibody (through a different company), I have been anxiously awaiting this day. This stuff was the only thing that has worked in preventing and lessening the severity of migraines for me. I am elated, not only for myself but also for my fellow migraineurs who have not yet had the opportunity to see if this will offer them relief from migraine hell. Praying that this gets on the market quickly.

  • Joanna Bodner moderator
    7 months ago

    Thanks so much for sharing your experience with us & that you in fact were receiving good results while you were in it! That is very encouraging to hear! Do you plan on talk to your doctor about it? Keep us posted!! Thanks again for the comment. Warmly, Joanna (Migraine.com Team)

  • Poll