FDA Approves Injectable Migraine Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a monthly self-injected drug for the prevention of migraine in adults.

Aimovig (erenumab) is the first FDA-approved migraine treatment in a new class of drugs – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate. It blocks the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

"The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine," said Sean Harper, MD, executive vice president of Research and Development for Amgen, which shares the licensing rights to Aimovig with Novartis.

The effectiveness of Aimovig for the prevention of migraine was evaluated in three clinical trials, which found that patients experienced one to 2.5 fewer migraine days per month compared to those who took a placebo. The most common side effects were irritation at the injection site and constipation. 

Like many specialized drugs used to treat chronic conditions, Aimovig comes with a hefty price tag. Amgen says the drug will cost about $6,900 a year, or $575 for each monthly dose.

Out-of-pocket costs will vary for patients depending on their insurance. Amgen has a co-pay program for Aimovig that could reduce the cost to as little as $5 per month for eligible patients.

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The company says Aimovig will be available to patients within one week.

"Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart  Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of two percent due to adverse events – and experienced sustained migraine prevention."

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

About one-third of migraine sufferers can predict the onset of a migraine because it is preceded by an aura – a sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks, triggered by stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet.

Amgen and Novartis expect Aimovig to be approved in the European Union in the next few months. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.