FDA Approves First Migraine-Preventing Drug

The first of a new class of drugs designed to prevent migraines was approved by the FDA yesterday, and it’s expected to be available to sufferers of this debilitating form of headache as early as next week.

The drug, Aimovig, made by Amgen and Novartis, is given by once-monthly self-injections with a device similar to an insulin pen. It’s the first FDA-approved preventive treatment that works to prevent migraine attacks by blocking the activity of a protein in the brain (calcitonin gene-related peptide) that contributes to them. Several other drug companies are now running clinical trials or awaiting FDA review on other new treatments in this same class of drugs that target the same molecule. 

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According to the Eric Bastings, the deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, the newly approved drug “provides patients with a novel option for reducing the number of days with migraine.” But it’s expensive, with a $575 monthly price that doctors say they hope will be covered by most insurance. 

The effectiveness of Aimovig in preventing migraines was evaluated in three clinical trials. In each, the number of monthly migraine days was cut by between one and 2.5 days, depending on factors like whether the subject had episodic or chronic migraines, and how long they took the medicine. 

Rashmi B. Halker Singh, a neurologist at the Mayo Clinic in Phoenix who helped run the trial there, said some "super responders" to the drug saw "a dramatic benefit" from it, and others saw the days they suffered from migraines cut by a very respectable 50 percent. As she tells it, "There is a lot of promise in this drug making a substantial difference for a disease that affects millions of Americans and that is likely underdiagnosed." 

While the drug doesn’t eliminate migraines, it is expected to greatly improve the quality of life of migraine sufferers, for whom other available drugs — most taken at the onset of symptoms like intense throbbing on one side of the head, nausea, and sensitivity to light and sound — come with what’s been described as “intolerable” side effects, like weight gain and mental fogginess, that have often led patients to stop taking them.

The most common side effects to patients in the clinical trials for this drug were reported as injection site reactions and constipation. 

The drugs could help many of the 2.8 million Americans who have a migraine several times each month. (Overall, nearly 39 million Americans experience migraines, and they are one of the top 10 causes of disability.) Migraines are three times more common in women than in men and affect more than 10 percent of people worldwide.