These revolutionary medicines for the prevention of migraine simply destroyed clinical trials – tech2.org

These revolutionary medicines for the prevention of migraine simply destroyed clinical trials



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A series of advanced drug trials show great promise for a completely new generation of migraine prevention drugs, which could reach the market next year.

For the millions of patients with migraine worldwide, this is the most welcome news in decades, since current treatment options are limited and until now there were no preventive drugs against migraine. Until now.

These new drugs are monoclonal antibodies, laboratory-made proteins of the type our immune system deploys to attack various substances in the body. In the case of migraine, these antibodies are directed to CGRP (peptide related to the calcitonin gene), a molecule known to play a role in migraines.

Although sometimes people think that migraines are a type of severe headache, the debilitating condition a lot of symptoms that include nausea, vomiting, sensitivity to light and noise and fatigue.

A migraine attack can last from a few hours to several days, and the vast majority of patients (more than 90 percent) suffer from episodic migraine, which means less than 15 days per month. Chronic migraine can be more than 15 days per month and can have serious effects on a person's well-being.

Anyone who has had problems with migraines will know that there are many medications to treat. For example, there are some specific migraine medications that people can take as "rescue" medicine when a migraine attack occurs.

In addition, for more frequent migraines, a patient may try to take one or more medications to prevent attacks. But none of those drugs developed specifically for migraines, but they are antidepressants, blood pressure medications or anti-epilepsy medications, often with serious side effects.

That's why this new clbad of CGRP-addressing drugs is so important. And two high-quality studies published last week in New England Journal of Medicine show that pharmaceutical companies are on the right track.

One of these trials named STRIVE the proven injections of the drug erenumab as a preventative of episodic migraine in 955 patients in 121 study sites over a period of six months.

The team discovered that in their study population of episodic migraines with a baseline of 8.3 days of attack per month, erenumab could reduce that number in 3.2 days with a dose of 70 mg and in 3.7 days with a higher dose of 140 mg.

In the highest dose group, half of the patients experienced a reduction of 50 percent or more of the average number of days of migraine, which means that of all the days that they lost a migraine each month, They recovered at least half of that precious time.

"The results of STRIVE represent a real transition for migraine patients from reused and poorly understood treatments to a specific therapy designed for migraine," says lead researcher Peter Goadsby of King & # 39; s College Hospital in London and the NIHR-Wellcome Trust King & # 39; s Clinical Research Facility.

Erenu mab works by blocking the CGRP receptor in the brain, and it is the only drug that does it. It is being developed by Amgen and Novartis, who sponsored the study, and the companies announced that the FDA accepted the presentation of their medications earlier this year.

But there are also other pharmaceutical products in that race. The results of the trial for a different drug called fremanezumab (developed by Teva Pharmaceuticals) were also published last week; this was tested in 1,130 patients with chronic migraine.

When injected quarterly for 12 weeks, the drug achieved a reduction of 4.3 days in days of average headache, of 13.2 days per month. Unlike erenumab, this drug targets the CGRP molecule.

The important thing about these trials is that the drugs definitely outperform placebo, but the researchers acknowledge that more research will be needed to determine if the drugs continue to work and remain safe in the long term.

One thing is for sure, we will hear more and more about monoclonal antibodies from CGRP, since two other companies, Eli Lilly and Amgen, also have their own version in the pipeline and there is talk that at least one of these four drugs will end on the shelves of pharmacies next year.

Unfortunately, the only big catch could be the cost. While it is too early to talk about the final price before actual drug administration approvals, there are some predictions that injections of these new drugs could cost at least US $ 8,500 a year.

We can only hope that fierce competition in this area could reduce the price a bit.

"STRIVE, as is the case with monoclonal antibody developments in general, represents an incredibly important advance in the understanding of migraine and the treatment of migraine," says Goadsby, who is also a co-author of the fremanezumab study last week.

"Too often, migraine is trivialized as a simple headache when, in reality, it can be a debilitating chronic disease that can destroy lives," says Simon Evans of the British charity Migraine Action.

I hope this marks the beginning of a real change in how this condition is treated and perceived. "

The latest trials were published in New England Journal of Medicine here and here.

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