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News: FDA Approves New Drug for Migraine Prevention

News: FDA Approves New Drug for Migraine Prevention

This first-of-its-kind medication is set to release this week.

Migraines, a type of moderate-to-severe headache, affect 39 million Americans and a whopping 1 billion people around the world, according to the Migraine Research Foundation. And if you’ve ever experienced one, you know it can be debilitating—bringing about severe pulsing or throbbing pain, light or sound sensitivity, vomiting, auras or visual problems that can include flashing lights or zig-zag lines.

But there’s good news for those with migraines: the US Food and Drug Administration (FDA) has approved a drug called Aimovig (erenumab-aooe) to prevent these oftentimes unbearable headaches.

The drug, jointly produced by pharmaceutical companies Amgen and Novartis, is a monthly self-injection and the first medication in its class initially approved and developed specifically for migraines. (Most other migraine drugs were originally developed for other conditions.) Numerous studies found it to be an effective treatment for those with chronic migraines—migraines that occur 15 or more days per month—or episodic migraines, migraines that occur 4 to 14 days per month.

How the drug works
Aimovig works by blocking calcitonin gene-related peptide, a driving molecule behind painful migraine episodes. If taken monthly, the treatment can lessen the number of migraine days per month.

To determine Aimovig's efficacy, researchers studied patients with both chronic and episodic migraines in three separate clinical trials. One study evaluated 955 patients for six months, another followed 577 patients for three months and the last followed 667 patients for three months. In each study, some patients were given Aimovig, while otheres were given a placebo. The new drug reduced the number of monthly migraine days by up to 2 ½ days compared to the placebos. The most common side effects noted (occurring in less than 2 percent of patients from one of the studies) were constipation and irritation around the injection site.

What it means for people with migraines
There are no known cures for migraines and the causes are not completely understood. For years, doctors have prescribed anti-seizure, blood pressure, antidepressant and pain-relieving drugs to reduce the number of a patient's migraines or minimize symptoms when they do arise. They've also urged patients to address certain habits which can trigger migraines—things like stress and anxiety, hormonal changes, bright or flashing lights, lack of sleep, not eating or eating certain foods.

“We need new treatments for this painful and often debilitating condition,“ said Eric Bastings, MD, the deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in the FDA’s official press release. This new drug, it's believed, is a step in the right direction, both for migraine awareness and for prevention. Other drugs that work in a similar way are in development, as well.

Aimovig's list price is $575 per month for 70 or 140 mg injections—your out-of-pocket costs will depend on your specific insurance coverage. The drug should be available this week to those patients with chronic or episodic migraines; ask your doctor if it's right for you.

This article was published on May 22, 2018.

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