On Thursday, the U.S. Food and Drug Administration (FDA) approved the first drug designed to prevent migraines.
The drug, called Aimovig, is administered via monthly self-injections and works by blocking the activity of the calcitonin gene-related peptide (CGRP). CGRP is a neurotransmitter found in increased amounts in the blood during a migraine and is believed to play a role in migraine. The drug uses antibodies to block the receptor on the cell surface that CGRP needs to bind to in order to work.
The drug is expected to be available to patients in one week. Amgen, the pharmaceutical company manufacturing the drug alongside Novartis, has set the list price at $6,900 a year or $575 monthly. It’s unclear how much of this would be covered by insurance. Amgen said its Aimovig Copay Program may help reduce out-of-pocket costs for patients with commercial insurance to as low as $5 a month.
Three clinical trials evaluated the effectiveness of the drug. The first looked at 955 participants with a history of episodic migraine, or four to 14 migraine days a month. People taking Aimovig for six months had an average of one to two fewer migraine days a month compared to those on the placebo. The second study included 577 patients with episodic migraine and found that those on the drug for three months had one fewer migraine day a month compared to those on the placebo. The third study looked at 667 people with chronic migraine (more than 15 migraine days a month) for three months and found those using Aimovig had two and a half fewer migraine days than those taking the placebo.
A final “phase 3B” study looked at 246 patients with episodic migraine who had two to four previous treatments fail. Those taking Aimovig had three times higher odds of having their migraine days cut in half, compared to those on the placebo.
Until now, drugs used to prevent migraine were designed to treat other conditions, like depression and seizures. These drugs often come with side effects and their effectiveness is limited. In the clinical trials, participants taking Aimovig didn’t report any more side effects than those in the placebo group. The most common were pain at the injection site and constipation.
It’s unclear what, if any, side effects may arise as a result of long-term use and how the drug’s effectiveness is affected by the various migraine types people experience (i.e. migraine with aura, vestibular migraine).
Tony Hooper, executive vice president of global commercial operations at Amgen, told Bloomberg they expect patients will take Aimovig if they have tried and failed other options.
Reference The mighty