Aimovig is injected by the patient once a month and works by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks, the FDA announced in a press release.
At $575 an injection ($6 900 per year), the drug made by Amgen and Novartis and currently only available in the US, is expensive.
Migraines are more than just headaches. They cause severe throbbing and pulsating pain usually on just one side of the head. They are accompanied by nausea, vomiting and extreme sensitivity to light and sound. Attacks cause significant pain for hours to days and can be so severe that they become debilitating.
Approximately one-third of migraine sufferers can predict the onset of a migraine attack because it is preceded by an aura, the FDA reported. These are transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision.
In Phase II and III studies in chronic and episodic migraine, Aimovig resulted in significant reductions in monthly migraine days and the use of acute migraine medications. These effects on monthly migraine days (four to 14 headache days per month) were shown to be sustained for up to 15 months in an ongoing study in episodic migraine.
According to the FDA and Novartis, the most common side effects participants experienced were constipation and injection site reactions.
Current prevention treatments for migraines include drugs originally developed for other conditions, such as epilepsy, but many of these drugs come with serious side effects. The wrinkle reducer Botox has also been approved as a migraine treatment.
More than 10 percent of people worldwide suffer from migraines, and they are three times more common in women than in men. Migraine attacks can be triggered by a variety of factors, including certain types or lack of food, lack of sleep, the weather, hormonal changes, bright lights and stress.