FDA approves first drug for migraine prevention

May 22, 2018 by Medigroup

The Food and Drug Administration announced May 17 that it would approve a novel drug treatment for migraines for prescription in the U.S. The compound, being marketed under the name Aimovig by pharmaceutical makers Amgen and Novartis, is the first FDA-approved drug for the prevention of migraines. While a variety of substances have been developed or prescribed for similar uses, Aimovig is the first one to be approved specifically for migraine sufferers, and may be among the first medications to effectively prevent them in many patients without inducing severe side effects.

More on migraine

Migraines are among the most common chronic health conditions in the world, and one of the most costly. In the U.S., it is estimated that 20 percent of women and between 6 to 10 percent of men suffer recurrent migraine episodes. The complication also ranks among the top 10 most common causes of long-term disability. Globally, one in seven people are believed to suffer from periodic migraine.

Migraines are distinguished from general headaches in many ways:

• They have no underlying cause that can be clinically diagnosed, such as trauma or malnutrition.
• They are recurrent – chronic migraine is defined by the presence of 15 or more headache days per month for at least three months.
• They are sometimes triggered by external factors, like missing meals, lack of sleep, stress or certain foods.
• They tend to present their own unique symptoms, including nausea, weakness, vision impairment and others. Some of these symptoms may persist even after the pain has subsided.
• There may be a genetic or hereditary component, as a family history of migraine is common in patients.

Migraines have been described in ancient texts and appear to have been a persistent health problem throughout history. Yet effective treatment, or even a full understanding of what causes the condition, has proven elusive. In modern times, medical professionals could, at best, advise migraine patients to track their symptoms for possible triggers to then avoid in the future. Various drug treatments for migraines include a broad classification of substances, from over-the-counter analgesics like ibuprofen, to anti-seizure medications, antidepressants and many others that alter brain chemistry. For migraine prevention, some drugs normally used to treat high blood pressure have been prescribed. However, few of these treatments have shown significant efficacy in a majority of patients. Worse, they often introduce undesirable side effects that can be severe.

Details on new treatment

Aimovig (known generically as erenumab), the drug recently approved by the FDA, is unique from other chemical migraine treatment regimens in several ways. The drug is administered as a monthly injection that patients can perform themselves, unlike most other treatments that require daily dosage with tablets. Aimovig is thought to work by blocking a protein called CGRP, which is normally active in the brain and throughout the body in pathways related to pain and blood pressure. Chronic migraine patients are believed to display higher incidence of a genetic mutation that causes CGRP to become overactive, thus leading to recurring migraine episodes. Aimovig injections contain antibodies that can latch onto CGRP and deactivate it.

Recently, drugs similar to Aimovig (called human monoclonal antibodies) have been rapidly developed and found to be effective in the treatment of immune disorders and certain types of cancer. Aimovig is the first drug of its kind to earn FDA approval for the prevention of migraines, but similar medications from other pharmaceutical firms are also on track for approval in the very near future. A full year of treatment is expected to cost $6,900 before health insurance benefits.

In clinical trials, Aimovig was found to reduce the frequency and severity of migraine attacks in chronic patients, although it did not prevent all episodes. Still, this is considered much more effective than other standard treatments. Researchers also found that it did not appear to induce serious side effects, and was both more effective and as tolerable as placebo. Still, as with any new drug, doctors will need to continue monitoring patients before the scope of any long-term side effects are known.

What this means for migraine patients

For now, the primary concern around Aimovig is the drug’s high cost. Even with insurance coverage, brand new medical treatments are often expensive for patients, although this tends to subside over several years. Even so, a report from the nonprofit Institute for Clinical and Economic Review determined that for many people who experience chronic migraine, the potential benefit of the drug may outweigh its cost. That’s especially true in comparison to the medication that doctors typically prescribe to treat chronic migraine – the ICER review estimated that 85 percent of chronic migraine patients stop taking their medication within the first year of treatment because the side effects can be more debilitating than the condition itself. ICER concluded that even at a cost as high as $8,500 per year, Aimovig could provide reasonable improvement in quality of life relative to the expense for many patients.

As more novel treatments for an extremely prevalent condition come to light, migraine sufferers may have more options to alleviate their pain very soon.