Emgality

3 February 2022

What’s New With Galcanezumab (Emgality)? (You Might Qualify For These Trials)

Emgality, also known as galcanezumab, is a CGRP inhibitor for both migraine and cluster headache, is the subject of a lot of study right now, and you may qualify to be involved.

For migraine, galcanezumab is taken once a month, as a preventative. For cluster headache, it is also taken once a month at the start of and during a cluster period. Although most people aren’t fans of injections, the fact that injections are so far apart is certainly a selling point.

But now galcanezumab is being tested for other conditions. Most notably, vestibular migraine, small fiber neuropathy, and fibromyalgia.

The vestibular migraine study is a study in the USA for adults with vestibular migraine or probably vestibular migraine. You can check out the details and see if you qualify here: Galcanezumab for Vestibular Migraine

The second study covers both small fiber neuropathy and fibromyalgia, and is also in the USA. Find out if you qualify here: Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia

Researchers also continue to investigate the general function of galcanezumab, including further studies to see how it works with migraine. Other general studies you may qualify for include:

Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action (looking for adults with migraine)
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (CHALLENGE-MIG) (adults with migraine)

There are also a couple of studies happening for teens and children:

For more information on Emgality in general, as well as savings programs, visit their official US site here. For Canadian patients, a pdf summary here. England, Scotland and Wales information here.

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.

19 June 2019

“First FDA-approved drug that reduces the frequency of attacks of episodic cluster headache”

James Discoveries & Stats, News, Treatments 0

Earlier this month in the USA, the FDA approved Emgality (galcanezumab) for use with episodic cluster headache. This is a big step for CGRP inhibitors, which have shown promise for treating both migraine and cluster (for example, see this article about Ajovy).

As the official Emgality site states:

For adults with episodic cluster headache: Emgality can help reduce the number of weekly cluster headache attacks that occur during a cycle
Emgality.com

As mentioned before, CGRP inhibitors have shown promise for episodic cluster headache treatment, but the treatment of drugs like Emgality is far from a magic cure.

While most of the articles about the recent FDA approval point to the 8.7 fewer attacks per week during a cluster cycle, there is more to the story.

Patients experienced 8.7 fewer attacks, with only 5.2 fewer attacks with placebo. Significant enough to show that Emgality seems to be doing something, but by no means a silver bullet.

But that was in the middle of the trial, which was an 8 week trial. After two months, the difference between Emgality and placebo was even less – a difference which some say “is no longer statistically significant” (see Galcanezumab Offers Help for Cluster Headache and Migraine).

It is good news that cluster patients have something else to try – and we hope that Emgality will help some. But much more needs to be done to help cluster headaches. Sadly, this is only a small step toward better treatment.

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 January 2019

New Migraine Meds in a New Year – and should I care?

James Highlights, Medications, News 1

Although I wouldn’t recommend that anyone pin all their hopes on the up-and-coming migraine medications, yes, there are some reasons why you should care about the new meds that are out, and the new ones we may see this year (and beyond).

So let’s take a quick look at what’s been happening:

Over the past few months, three medications have hit the market. All three are CGRP inhibitors, a new class of targeted migraine medication.

Aimovig (erenumab) – self-injections once a month as a migraine preventative.
Ajovy (fremanezumab) – self-injections either monthly or quarterly for migraine prevention. May also be useful for episodic cluster headache.
Emgality (galcanezumab) – self-injections monthly. Has shown promise for both chronic and episodic migraine.

Yes, although all the same “class” of medication, each of these is different, with advantages and disadvantages. One may work where another may not. Readers may especially notice from the above list that Ajovy can be taken quarterly instead of monthly – that’s 8 few injections a year.

So what can we expect next from this class of medications? Here are three more that should hit the market in the months ahead:

Ubrogepant – this one is an oral abortive – swallowed when needed to stop a migraine attack.
Eptinezumab – self-injection, quarterly. Showing promise for chronic and episodic migraine. Already being promoted as a very “fast acting” option.
Rimegepant – oral medication, used either as an abortive or a preventative.

A lot of the differences between these medications aren’t listed above – and some will vary from patient to patient. However, notice that now we have more oral options, and more abortives (taken when the attack hits). So those who hate injections (even though injection technology is improving quickly, and is not as bad as it once was) have hope.

What else does this mean, besides the fact that one may work and one may not for you?

A lot of people are speculating what this will mean for price. At the moment, each of these are similarly priced. However, at the very least, it’s important to be aware of the special programs each of company will put in place, and how they will change. Especially early on, these companies will want to gain customers. There are ways to save money.

Also, these companies will want to promote what they see as benefits of their particular brand – so watch for that. Also, many are trying to gain customer loyalty by providing other services, such as helpful info or apps for your phone. Watch for that as well.

As we’ve talked about before, even as new anti-CGRP meds flood the market, a whole new class beyond that is being developed. Though not expected anytime soon, watch for news about:

ALD1910 – being developed by Alder Pharmaceuticals (developers of eptinezumab) as a migraine preventative.
AMG 301 – being developed by Amgen/Novartis (makers of Aimovig) as a migraine preventative.

For another perspective on the class of migraine drugs currently hitting the market, see A Crowded Field for Migraine Therapies, Where Recently There Were None.