fremanezumab

2 December 2019

Botox vs. CGRP Inhibitors – the fight begins…

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.

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.

5 January 2018

More Clues about how CGRP Drugs will Prevent Migraine

James Discoveries & Stats, Medications 0

As we continue to wait for the first CGRP inhibitors to hit the market, clinical trials are giving us more clues about how the medications will actually work.

One of the most interesting trials was published at the end of November. Fremanezumab was the drug, and the target group was patients with chronic migraine (that is, headache pain more than 15 days per month, and specifically migraine attacks at least 8 days).

One group received 675mg every three months by injection. Another group had a 675mg injection the first month, then 225mg the next two months.

Now, let’s look at the results.

fremanezumab trial This is a helpful chart, but let me explain it. There are three sets of data. First, those who had a quarterly injection (before, and after, basically), then those who had a monthly injection, and then a placebo.

So you’ll see that the quarterly and monthly injections were very similar, with the monthly being slightly better. Essentially, about four and a half headache days disappeared on average, or about a third.

Now we know that every patient is different, so here’s some other interesting information. Almost 40% of patients had a 50% reduction in headache days.

I don’t know if you noticed the same thing that I noticed or not, but here it is. The quarterly group and monthly group were very similar. So – for many patients, a quarterly injection may make a huge difference in their lives.

I realize some people hate injections, but for a lot of people, an injection every three months will be a lot better than a pill twice a day.

Obviously with a brand new medication we’re still learning about which doses work best. So hopefully we can find ways to use CGRP inhibitors which will show an even greater improvement for many chronic migraine patients.

You can read more about the study here: Fremanezumab for the Preventive Treatment of Chronic Migraine

26 June 2017

More Positive Results from the CGRP Migraine Treatments

James Uncategorized 0

It probable won’t be helpful to report in detail on every single CGRP inhibitor going through trials and coming to the market, but I will focus on one more today, just to point out that the competition is heating up.

CGRP targeting medications are not miracle drugs that will finally cure migraine. They are, however, another option – and a unique direction in treatment. That means that some people who have not been helped by other medications and treatments will have a new and different treatment to try.

Last month another trial was completed for fremanezumab, also known as TEV-48125. Fremanezumab is being developed by Teva Pharmaceutical Industries Ltd. Teva hopes to apply to the FDA for approval later this year, to use with both episodic and chronic migraine.

In this recent trial, the new medication cut down on days with migraine each month, as was reported with galcanezumab. In the past researchers have noted that fremanezumab has helped patients in clinical trials who were not having success with their current medication.

In the race to get to the market in the USA, one step ahead of both fremanezumab and galcanezumab is erenumab. The makers of this drug, Amgen, submitted a Biologics License Application (BLA) to the FDA in May.

But these won’t be the only three in this class of medication, if all goes well. Eptinezumab (formerly ALD403) also continues in clinical trials with positive results so far.

The good news is that each one of these drugs is a little different, and may help different people in different ways. Also, this may open up further migraine research and treatments that work better at targeting the migraine chain-reaction.

A cautionary note at this stage, however. The market-watchers are well aware that these medications mean billions of dollars – yes, billions. We can expect that the prices may be high, and also that the hype may outweigh the actual helpfulness of the new treatments.

But with these cautions in mind, many remain hopeful that many people will be losing fewer days to migraine – and that means more days to be productive, and to enjoy time with friends and family.