“We hope this marks the start of real change.”
A series of late-stage drug trials are showing great promise for a completely new generation of migraine prevention drugs, which could hit the market as early as next year.
For the millions of migraine sufferers around the world, this is the most welcome news in decades, as current treatment options are limited and no migraine-specific prevention drugs even existed – until now.
These new drugs are monoclonal antibodies – lab-made proteins of the kind that our immune system deploys to target various substances in the body. In the case of migraine, these antibodies target CGRP (calcitonin gene-related peptide), a molecule known to play a role in migraines.
Although people sometimes think of migraines as a type of bad headache, the debilitating condition actually comes with a host of symptoms including nausea, vomiting, light and noise sensitivity, and fatigue.
A migraine attack can last from a few hours to several days, and the vast majority of sufferers – over 90 percent – have episodic migraine, which means fewer than 15 days per month. Chronic migraine can be more than 15 days per month, and can have severe effects on one’s wellbeing.
Anyone who’s struggled with migraines will know there’s a bunch of medications out there to try. For example, there are a few migraine-specific drugs people can take as ‘rescue’ medicine when a migraine attack happens.
Additionally, for more frequent migraines a patient can try to take one or more medications to prevent the attacks. But none of those drugs were actually developed specifically for migraines – instead, they are things like anti-depressants, blood pressure medication or anti-epilepsy drugs, often with serious side-effects.
Which is why this new class of CGRP-targeting drugs is such a big deal. And two high-quality studies published last week in the New England Journal of Medicineshow that pharmaceutical companies are on the right path.
One of these trials called STRIVE tested injections of the drug erenumab as a preventative for episodic migraine in 955 patients across 121 study sites over the span of six months.
The team found that in their study population of episodic migraines with a baseline of 8.3 attack days per month, erenumab could reduce that number by 3.2 days at a 70-mg dose and by 3.7 days at a higher, 140-mg dose.
In the higher-dose group, half of the patients experienced a 50 percent or greater reduction of the mean number of migraine days, which means that from all the days they’d lose to a migraine every month, they got at least half of that precious time back.
“The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy,” says lead researcher Peter Goadsby from King’s College Hospital in London and NIHR-Wellcome Trust King’s Clinical Research Facility.
Erenumab works by blocking the receptor of CGRP in the brain, and is the only drug to do so. It’s being developed by Amgen and Novartis who sponsored the study, and the companies have announced that the FDA has accepted their drug filing earlier this year.
But there are other pharmaceuticals in that race as well. Trial results for a different drug called fremanezumab (developed by Teva Pharmaceuticals) were also published last week – this one was tested in 1,130 chronic migraine patients.
When injected quarterly for 12 weeks, the drug achieved a 4.3 day reduction of average headache days from a whopping 13.2 days each month. Unlike erenumab, this drug targets the CGRP molecule itself.
The important takeaway from these trials is that the drugs are definitely performing better than placebo, but researchers acknowledge that more research will be needed to determine whether the medications continue to work and remain safe in the long term.
One thing is for sure, we’ll be hearing more and more about CGRP monoclonal antibodies, since two other companies – Eli Lilly and Amgen – also have their own version in the pipeline and there’s talk that at least one of these four meds will end up on pharmacy shelves next year.
Unfortunately, the one big catch might be the cost. While it’s too soon to tell about the final pricing ahead of actual drug administration approvals, there are some predictions that injections of these new drugs could end up costing at least US$8,500 a year.
We can only hope that the fierce competition in this area might bring the price down somewhat.
“STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment,” says Goadsby, who also co-authored the fremanezumab study last week.
“Migraine is too often trivialised as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives,” says Simon Evans from the UK-based charity Migraine Action.
“We hope that this marks the start of real change in how this condition is treated and perceived.”