The FDA Has Approved 3 Migraine Drugs… What You Should Know About Them

For decades, migraine relief was limited to conventional painkillers or treatments originally intended for other diseases.

A new type of drug may radically change how we treat this intensely painful condition. This year, three versions of that medication from three different companies have been approved by the U.S. Food and Drug Administration (FDA).

The new drug class has been proven to reduce the chance and severity of migraine attacks. These drugs work by blocking the action of a protein fragment called calcitonin gene-related peptide (CGRP).

CGRP not only initiates migraines, but it can also prolong and intensify the attacks.

The new medications involve a monthly injection that belongs to a category of drugs called monoclonal antibodies. These are immune cells that have been engineered to either block CGRP or its receptor.

The first two FDA-approved migraine-inhibiting drugs were fremanezumab (Ajovy) and erenumab (Aimovig).

Late last month, Eli Lilly announced its new drug, galcanezumab (Emgality), was approved by the FDA to become the third available CGRP blocker on the market.

Migraine is a neurologic event

The American Migraine Foundation estimates migraine headaches affect 38 million Americans.

Migraines affect three times more women than men. The condition can be a disabling one due to the intense pain people experience.

Dr. Deborah Reed, FAHS, the director of the Headache Program University Hospitals Neurological Institute in Ohio, told Healthline that migraine is more than just a headache.

It’s a neurologic event.

“Neurochemicals change and get released in the sensory areas of the brain that modify how neurons fire. The neurons fire much more easily when a migraine is happening,” Reed explained.

“Sensations that are normal, like light, sound, smell, and touch, become unbearable,” she added. “You will often see a migraine sufferer wearing glasses indoors or retreating to a dark quiet room when the migraine occurs. Digestion slows, and vomiting and nausea can occur.”

Emgality effectiveness

Two recent studies — EVOLVE-1 and EVOLVE-2 — were conducted over a six-month period to investigate the efficacy of 120-milligram (mg) and 240-mg doses of Emgality.

The findings indicate that in both studies, both dosages were significantly better than a placebo to reduce the average number of migraine attacks experienced on a monthly basis.

Both studies also showed that a significantly larger percentage of participants receiving either dose of Emgality, compared to those taking a placebo, achieved at least a 50 percent, and in some cases, 75 percent reduction in monthly attacks.

In a small number of participants, there was a total prevention of migraine attacks over the six-month trial.

Reed is excited about these new drugs.

“They are unbelievably good for many of my patients,” she said. “They are changing the way headache medicine will be practiced. I am treating patients with some of the worst migraine headaches and seeing great results.”

Long-term effects unknown

CGRP is a substance the body uses for many important functions.

It not only plays a role in regulating blood pressure, but also restores blood flow after a stroke or heart attack. It’s used in the healing process.

A 2017 review article reports that because CGRP is involved in many bodily functions, there may potentially be adverse effects after long-term use of migraine drugs.

The researchers believe that blocking this essential protein could possibly affect the cardiovascular system and other areas that use CGRP, such as the skin, pituitary gland (which regulates many essential hormones), and the digestive system.

Reed thinks this is why “one of the side effects is the mild constipation that some patients have experienced.”

However, she also says the thousands of study participants who reported only minor side effects give her a lot of confidence about safety.

Who should avoid these drugs?

According to an editorial by Dr. Elizabeth W. Loder, MPH, published in the Journal of the American Medical Association, there are some people who should avoid using the new migraine drugs.

“If you experience infrequent migraines and respond well to medicines used to treat individuals then you probably do not need these therapies,” she writes.

Loder adds it’s better to avoid these medications if you have or are at risk for cardiovascular disease.

Also, if you’re pregnant or trying to conceive, the long period that CGRP blockers stay in your system — over a month — could pose a risk to the fetus.

Differences between the drugs

All three approved drugs have the same mechanism of action.

Each treatment works by blocking stimulation of the CGRP receptor, which prevents dilation (expansion) of the blood vessels. That’s thought to cause the brain inflammation that initiates or contributes to migraine headaches.

Only time will tell if one drug offers better results with the least side effects, which is easiest for patients to take, and which will be the cheapest.

“Of course, as a drug is brought to a larger patient population, there may be some unexpected results. I think we all learned that with the Vioxx scare. I don’t foresee any at this point, though,” Reed said.

Right now, all three medications are expected to cost about $600 per month.

Each manufacturer currently has a program in place to defray much of the out-of-pocket cost for commercially insured patients.

The bottom line

CGRP-blocking drugs are a revolutionary development in migraine treatment and prevention.

There are now three different brands of this new drug type approved by the FDA.

Each one works by preventing CGRP from dilating blood vessels, a process believed to be something that can start and even intensify migraine headaches.

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