Ajovy

22 October 2020

What Is Surprising Us About The New CGRP Preventatives?

James Discoveries & Stats, Medications, News 0

Can you believe it? It was in the spring of 2018 that Aimovig (erenumab) was approved in the USA. My! Time flies!

Really, all the CGRP related drugs are still extremely new, when it comes to prescription drugs for migraine. Long term trials are still a future hope. And we’re just starting to guess at some trends that we may be seeing from patients.

But what are some of the trends we’re seeing? Let’s take a moment to talk about them, and you can comment if you’ve had a similar of very different experience.

(1) For many, these drugs are working better than expected!

First, the (very) good news. For many patients, these CGRP inhibitors are working better than the clinical trials even led us to believe.

As drug companies rush to market new migraine drugs, we expect to see headlines that use phrases such as “life-changing!”. But in the case of drugs like Avojy and Aimovig, this does seem to be the case with many patients – a very significant improvement in their symptoms.

And these are not always “just any” patient. These are patients who have not had a lot of success with other medications.

So there are good reasons to have a lot of hope that these new drugs will help many more people around the world in the next few years.

(2) Sometimes these drugs are less effective after a while.

This is a biggie. Reports are coming in that, for many patients, the benefits tend to “wear off” after a while.

Will switching to another CGRP preventative help? It’s very possible, and it’s not at all a surprise that you may need to try more than one before you find the right fit.

But this is one that researchers are going to pay a lot of attention to in the next few years. Which patients are having this issue, and why? Will some CGRP preventatives work better than others? Even if they’re not as beneficial as they were in the first few weeks, do they still provide significant benefit? What’s your experience?

(3) Side Effects

Any surprises with side effects? Side effects are not a huge problem for many patients, but it is starting to sound like constipation is an issue for some, especially with Aimovig (and in this case, switching may provide significant benefit). It seems that it may be more likely to make constipation issues worse if you already have a pre-existing condition.

In a recent discussion published in The American Journal of Managed Care, two neurologists pointed out some of the other side effects they’re seeing – “. . . a worsening of Reynaud syndrome, fatigue, hair loss, sexual dysfunction, and in women, some reports of irregular menstrual periods.”

Again, discussing side effects shouldn’t make it sound like patients are running away from these medications in droves because they’re all having major problems. Side effects may be rare, but we have to keep an eye on them because certain patients may be more prone to certain side effects than others.

If you’ve been taking a new preventative, such as Vyepti, Aimovig, Ajovy, or Emgality, how long have you been on it? What has your experience been? Anything you might share could be a help for our community.

2 December 2019

Botox vs. CGRP Inhibitors – the fight begins…

James News, Treatments 0

Are the newcomers to migraine treatment really any better than Botox treatment?

That’s one of the key questions being asked now. And it’s an important one, because it’s affecting migraine patients and their insurance coverage.

Patient and doctors — Are important policies being decided “behind your back”?

For example, in England, NICE (National Institute for Health and Care Excellence) recently decided not to recommend Ajovy (fremanezumab) as one of the drugs provided under the NHS (National Health Service). Why? Because current evidence doesn’t show the Ajovy is that much better than Botox (onabotulinumtoxinA) for patients who have tried several treatments already. And if the difference in success is negligible, the difference in cost is not – onabotulinumtoxinA wins easily.

Botox, once the strange newcomer to migraine treatment, is now an old standard. And it may be difficult for policy makers and insurance companies to accept the newcomers, even if they may be better for some patients.

Interestingly enough, its affect on CGRP may be one of the reasons why onabotulinumtoxinA works for migraine patients, which may explain similar results. But we’re still waiting for some good head-to-head studies to really show us which is “better” – “better”, that is, for most patients in general, not necessarily better for you. Welcome to the real world. (Also see Botox and CGRP – and the Future of Migraine Treatment.)

If new studies confirm that Botox performs as well as CGRP inhibitors, of course doctors may want to recommend Botox first, as a less expensive option, to most patients. But Is that a reason to not recommend the CGRP inhibitors at all? Or not to cover it in an insurance policy?

~~Of course, all this has nothing to do with money and politics.~~ Well, ok, maybe it does. Allergan is busy trying to convince investors that Botox for migraine sales continue strong. And there is some evidence that onabotulinumtoxinA and CGRP inhibitors may turn out to be best friends, because the anti-CGRP drugs may help the migraine-fighting effects of Botox last longer (see Concurrent CGRP Inhibitor and OnabotulinumtoxinA Therapy Boosts Relief in Severe Chronic Migraine).

But with the current expense of the new drugs, and a lack of studies to show long term safety, Botox may still have a surprising advantage.

(You can see in detail the reasoning of NICE in their paper here: Fremanezumab for preventing migraine (pdf). Also see Results of The Migraine Trust’s latest patient survey to inform new migraine drug NICE consultation.)

10 April 2019

Misc News – Ajovy, N1-Headache, Summit Materials

James News 0

Here are a few tidbits from the world of migraine news that you will want to be aware of:

Ajovy in Europe: The new CGRP inhibitor for migraine, Ajovy (fremanezumab), is one step closer to hitting the pharmacies in Europe. Ajovy was recently granted “Marketing Authorization” from the European Commission. It’s approved for those with 4 or more migraine attacks per month, given as a pre-filled injection.

Full availability could still be months away, depending on the country. In the UK, Ajovy has already been submitted to the National Institute for Care and Health Excellent (NICE) for it to be available on the NHS, but their committee meeting won’t be until October.

N1-Headache (formerly Curelator), the popular app for tracking headache and migraine triggers and “protectors”, has released a new Q&A to help users make better use of the app. It explains some of the philosophy behind the various features, and should help most users use the app far more effectively. The Q&A can be viewed and downloaded in pdf format here: A Q&A with N1-Headache users

Migraine World Summit Materials: As this is written (a few days before publication), the folks at the Migraine World Summit intergalactic office are hard at work completing videos, mp3s, and pdfs of the Migraine World Summit 2019.

Many of people know that purchasing the summit gives you unlimited time to watch the videos online. However, many don’t realize that all the materials can be downloaded to watch or listen to anytime, anywhere.

And here’s another secret you may not be aware of. The pdf files – the transcripts of the interviews – are searchable. That means that you can search for information you’re looking for within a transcript. And, if you collect the transcripts in a folder, or use a program such as Evernote, you can search multiple transcripts for specific information that concerns you right now!

That alone increases the usefulness of the material a hundred fold. We’re thankful that the summit team outdid themselves getting practical useful information from the world’s leading experts. If you’re interested in the latest Migraine World Summit library, all the info is here.

1 February 2019

CGRP Antagonists: Not for Everyone? Experts Weigh in…

James Medications 1

When it comes to the new migraine drugs, such as Aimovig, Ajovy and Emgality, we can say, “So far so good”. Positive clinical trials, minimal side effects – there is legitimate hope that this new class of drugs will help many migraine patients.

That being said, specialists and researchers are not without their concerns about CGRP antagonists. So let’s take a quick look at what some of those concerns are.

Why would anti-CGRP drugs be a problem, if they fight migraine? CGRP seems to play an important role in sending pain signals. Lessening migraine symptoms by inhibiting CGRP seems to be working well for many people.

But here’s the catch – CGRP is in your body for a reason. If we lower CGRP levels, what will that affect? Our knowledge is limited, but it seems that CGRP has a wide range of important functions in the body. And the trials done so far are fairly short-term. What will the long term results be?

As Dr. Lawrence Robbins points out, “We will have a better feel for the true risk in 10 years.” Yes, but meanwhile?

Here’s the big challenge. Which patients will most benefit from these new meds? No one wants to spend more than is necessary – what if a cheaper treatment works better? And what if some patients have a higher risk of problems from anti-CGRP treatment?

Headache specialist Dr. Andrew Hershey wrote:

With the ongoing development of 4 different antibodies targeting the CGRP pathway, it will be difficult to determine whether unique patient populations will have a response to a specific drug or whether one agent is superior to others. Furthermore, many patients will probably still have a response to standard multidisciplinary treatment that is less costly in patient and provider time and dollars.”
Promise and Pitfalls of Preventing Migraine With CGRP Inhibitors

As we’ve already discussed, the clinical trials up to this point haven’t brought any major issues to light. But there is good reason to continue trials, and watch for problems.

Based on the science we have to date, what are the experts concerned about? What types of risk, or what types of concerns are they expressing? Here are a few of the top ones to watch for over the next few years:

Cardiovascular concerns: CGRP plays an important role in the cardiovascular system. For example it is involved in the dilation of blood vessels. Could long term use contribute to cardiovascular problems? The trials generally haven’t included groups at high risk. This is probably the biggest one specialists are watching for, and some may be reluctant to prescribe CGRP antagonists to those already at high risk for hypertension.
“Antidrug Antibodies and Immunoallergic Hypersensitivity”: Without getting into the details, this means that a drug can have a long term effect of causing unwanted immune responses, and/or the drug may become less effective as time goes by.
Hormones: Could these drugs interrupt proper hormone function? Specialists are especially watching those with thyroid problems, and also growth in children and adolescents (these drugs are only approved for adults for now).
Gastrointestinal disturbances: Could anti-CGRP drugs have a bad effect on your gut? Doctors will be especially watching those who have recently had ulcers or who have irritable bowel syndrome.
Pregnancy: Or, trying to get pregnant. Could CGRP interfere with pregnancy?

Again, we don’t have all the answers yet. These are concerns based on what we know about CGRP in the body, but there simply isn’t enough evidence to know the effect that these new medications will have, particularly long term. Hopefully, these issues will be minimal – or, in many cases, non-existent.

Some doctors may consider prescribing anti-CGRP medication for a time, and then having patients take a “drug holiday” for a while. Some may be hesitant to prescribe the drugs to those with cardiovascular or gastrointestinal problems.

Consider the risks – but remember, at this point, the risks seem to be small for most of us, especially if we’re not taking these drugs long term, and if we’re not already in one of the high risk groups above.

The question is not whether or not you should get the best possible treatment. The question is – what is the best possible treatment for you? Some patients will still find other treatments and combination treatments to be far superior and far cheaper than the new anti-CGRP drugs. Others will be helped by medications like Emgality, who have not been helped by other meds in the past.

As Dr. Amy R. Tso and Dr. Peter J. Goadsby wrote in 2017

An important task will be to attempt to identify patients more likely to benefit so personalized therapy can begin to offset the cost of the treatments by minimizing the number of patients treated who have no useful response.
Anti-CGRP Monoclonal Antibodies: the Next Era of Migraine Prevention?

For a summary of some of the challenges and concerns when it comes to this new class of drugs, check out Promise and Pitfalls of Preventing Migraine With CGRP Inhibitors. For a longer and more technical article for specialists, with many questions that may need to be answered, go to At Stake: The Possible Long-Term Side Effects of CGRP Antagonists.

3 October 2018

Ajovy for Migraine – and Cluster? Another New Drug

James Medications, News 0

Ajovy (fremanezumab-vfrm) (formerly called TEV-48125), a new anti-CGRP drug for migraine, was approved in the USA by the FDA last month.

Like Aimovig, Ajovy is taken by injection. It can be taken monthly, but unlike Aimovig it was also approved to be taken quarterly. A study that we talked about back in January showed that Ajovy was only slightly more effective when taken monthly. For many people, an injection every three months sounds a lot better than every month!

AJOVY You can read more about the history of this drug, along with more useful information, in the press release from Teva: Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults

So what about cluster headache? Though not yet approved for cluster, there are some signs that Ajovy and/or future anti-CGRP drugs may help a lot of cluster patients. If you’re interested in the technical details about the link between CGRP and cluster, check out For Your Patients-Cluster Headache: CGRP Implicated in Cluster Headache Attacks at Neurology Today.

Teva decided to scrap its trial of Ajovy for chronic cluster, when it didn’t look like the results would be as good as hoped. They do have high hopes for treatment of episodic cluster.

But even if Ajovy doesn’t turn out to be the best option for cluster patients, it does look very hopeful that one of the other CGRP related drugs may help bring significant relief.

Meanwhile, Ajovy is full-steam-ahead for migraine patients. For more information, visit the official Ajovy website here.