The Food and Drug Administration approved on Thursday the first drug designed to prevent migraines.
A once-monthly, self-injection, Aimovig is the first in a new class of long-acting drugs that is FDA-approved to specifically prevent migraines. It works by blocking the activity of a specific molecule, calcitonin gene-related peptide, that is involved in migraine attacks, the FDA announced in a press release.
The drug, expected to be made available to patients within a week, is made by Amgen and Novartis. Without insurance it will cost $575 for once monthly injections or $6,900 per year, Novartis said in a press release.
Migraines are more than just headaches. They cause severe throbbing and pulsating pain on one side of the head. They are accompanied by nausea, vomiting and extreme sensitivity to light and sound. Attacks cause significant pain for hours to days and can be so severe that they become debilitating.
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Migraine sufferers can sometimes predict the onset of an attack because it is preceded by an aura. Approximately one-third of migraine sufferers experience auras, the FDA reported. These are visual disturbances that appear as flashing lights, zig-zag lines or temporary loss of vision.
"Aimovig provides patients with a novel option for reducing the number of days with migraine," said Dr. Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We need new treatments for this painful and often debilitating condition."
Aimovig's effectiveness was studied in several clinical trials. The first tested the drug on 955 patients with a history of episodic migraines. Researchers compared the injection to placebo and found that over the course of six months patients treated with Aimovig had one to two fewer monthly migraine days on average than those treated with placebo.
In the second trial, researchers studied 577 patients with episodic migraines over the course of three months. Compared to placebo, those treated with the Aimovig injection had one fewer migraine day per month on average. The third study examined 667 patients with a history of chronic migraines over the course of three months. Compared to placebo, patients treated with the injection experienced 2.5 fewer migraine days per month.
Novartis reported that in a Phase 3b study, patients with episodic migraines who have failed two to four prior treatments had almost three-fold higher odds of having their migraine days cut in half when taking Aimovig compared to placebo.
According to the FDA and Novartis, the most common side effects participants experienced were constipation and injection site reactions.
Current prevention treatments for migraines include drugs originally developed for other conditions, such as epilepsy. However, many of these drugs come with serious side effects. The wrinkle reducer Botox has also been approved as a migraine treatment.
More than 10 percent of people worldwide suffer from migraines, and they are three times more common in women than in men. Migraine attacks can be triggered by a variety of factors, including certain types or lack of food, lack of sleep, the weather, hormonal changes, bright lights and stress.
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