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FDA Approves First Drug Designed to Prevent Migraine
Posted 5/30/18 (Wed)
The Food and Drug Administration (FDA) approved the first medicine designed to prevent migraines, spearheading what some experts believe will be a new era in treatment for people who suffer from the most severe form of headaches.
The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a device similar to an insulin pen. 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 F.D.A. approval.
These drugs do not prevent all migraine attacks, but can make them less severe and can reduce their frequency by 50 percent 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.
One in seven people worldwide experience migraines, among them 37 million Americans — as many as 20 percent of women, and 10 percent of men.
Some patients find the side effects worse than the migraines. Eighty-five percent of migraine patients stop taking the drugs within a year.
For a draft review of migraine drugs, the nonprofit Institute for Clinical and Economic Review surveyed patients with frequent migraines. Many said they did not make plans or commitments — even staying out of the work force — because they never knew when they would get a migraine that could disable them for hours or days.
In a preliminary analysis of cost-effectiveness, I.C.E.R. concluded that if the Amgen drug cost $8,500 a year, the price would be reasonable for the expected improvement in quality of life for patients with a migraine at least 15 times a month and no other options, said Dr. David Rind, the institute’s chief medical officer.
The group will publish a final analysis in two weeks, incorporating public input and the actual price of Amgen’s drug.