US approves 1st drug developed to prevent chronic migraines

WASHINGTON (WPVI) -- The FDA has approved a brand new treatment for migraine - the first specifically designed to prevent the crushing, debilitating pain.

Aimovig is given by monthly self-injections with a device similar to an insulin pen.

It's the first in a new class of long-acting drugs for preventing migraines, which block a molecule involved in igniting and sustaining migraines.

Dr. Zubair Ahmed, neurologist at the Cleveland Clinic, thinks it will be a game-changer in migraine care.

"We've never had any preventatives specifically designed for patients who have migraine. We've always used medicines for seizures or for blood pressure or antidepressants to help treat migraine at least as preventatives go," says Dr. Zubair.

Three other shots are expected to win approval by next year, and several pills for preventing migraines are being tested.

Current prevention treatments include pills originally developed for epilepsy and other conditions and the wrinkle reducer Botox.

But many patients abandon them because they don't help much or cause serious side effects.

Amgen Inc. of Thousand Oaks, California, and Swiss drug giant Novartis AG developed Aimovig.

The drug will cost $6,900 per year without insurance.

Migraines can cause disabling symptoms: throbbing headaches, nausea and vomiting, and sensitivity to light and sound.

About 10 million Americans get them frequently.

They're most common in people in their 30s, mostly women, and can last for several hours or even days.

In one study, patients given Aimovig saw their migraine days cut from eight to four a month, on average.

Those who got dummy shots had a reduction of two.

Each patient group had similar minor side effects, mostly colds and respiratory infections.

Some patients saw their migraines completely eliminated, said Sean Harper, Amgen's research director.

Aimovig and the migraine drugs in development target a substance called CGRP whose levels spike in the blood during a migraine, triggering symptoms.

The long-term safety of Aimovig, also known as erenumab, hasn't been tested, and Amgen plans to track outcomes in women who become pregnant while taking it.