The first medicine designed to prevent migraines was approved by the Food and Drug Administration (FDA) on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches.
The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a device similar to an insulin pen. The list price will be $6,900 a year, and Amgen said the drug will be available to patients within a week.
Aimovig blocks a protein fragment, CGRP, that instigates and perpetuates migraines. Three other companies — Lilly, Teva and Alder — have similar medicines in the final stages of study or awaiting FDA approval. The idea behind the new drugs dates to the 1980s, when researchers noticed that the protein fragment CGRP seemed to play a role in migraines. It transmits signals between nerves and also dilates blood vessels. Eventually, a fuller picture emerged: People who get migraines seem to make too much CGRP.
“The drugs will have a huge impact,” said Dr. Amaal Starling, a neurologist and migraine specialist at the Mayo Clinic in Phoenix, U.S. “This is really an amazing time for my patient population and for general neurologists treating patients with migraine.”
Millions of people experience severe migraines so often that they are disabled and in despair. These drugs do not prevent all migraine attacks, but can make them less severe and can reduce their frequency by 50% or more.
As a recent editorial in the journal JAMA put it, they are “progress, but not a panacea”.
Until now, drugs used to prevent migraines were designed to treat other diseases, like high blood pressure. They are not very effective, may work only temporarily, and often are laden with intolerable side effects.
In clinical trials, people taking the new drugs reported no more side effects than those taking a placebo. The side effects over the long term and among people with chronic diseases remain to be determined.
“For now, they look fantastic,” Dr. Stewart J. Tepper, a professor of neurology at Dartmouth College, said of the new drugs. “They shake the ground under our feet. They will change the way we treat migraine.”
A cause of disability
One in 7 people worldwide experience migraines — as many as 20% of women, and 10% of men. About 2% of the global population copes with chronic migraines. By some estimates, migraine is the third most common disease in the world, and it ranks among the top 10 causes of disability.
It is not just a headache: A migraine often is accompanied by disabling symptoms such as nausea and vomiting, difficulty speaking, and an aversion to light and noise. The headache can be throbbing and last for hours or days.
Patients often try the currently available treatments one after another, in varying combinations. Drug side effects are frequent and include mental fogginess, sedation, weight gain, sexual dysfunction and dry mouth leading to cavities.
Some patients find the side effects worse than the migraines; 85% of migraine patients stop taking the drugs within a year. NY TIMES
