New preventative migraine treatment from Amgen receives FDA approval

A novel treatment for the prevention of migraines, Aimovig (erenumab-aooe), has received approval from the US Food and Drug Administration (FDA).

The treatment, available from Amgen, is administered by the patient as an injection on a once-monthly basis. It works by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.

“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Dr Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.”

“Migraine is a serious neurological disease that has dramatic effects on patients' lives. Migraine patients experience excruciating headache pain, often accompanied by other symptoms such as nausea and vomiting, and many live in constant dread of the next attack,” stated Dr Sean E. Harper, executive vice president of Research and Development at Amgen. “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.”

Efficacy of the treatment has been assessed in three clinical trials, which included more than 2,000 participants. The first two studies looked at patients with a history of episodic migraine and the last those with chronic migraine. In all studies Aimovig was compared to placebo.

In all of the studies, treatment with Aimovig resulted in reductions in monthly migraine days and use of acute migraine medications when compared with placebo. Additionally, in an ongoing open-label extension study in episodic migraine these effects were shown to be sustained for up to 15 months.

“Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. 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 Dr Stewart J. Tepper, 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.”

“For years, the migraine community has been advocating for new treatment options that are specifically designed to treat migraine, a debilitating and often stigmatized disease,” explained Kevin Lenaburg, executive director of the Coalition For Headache And Migraine Patients (CHAMP), which represents 12 national headache and migraine patient advocacy groups. “Today we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days. On behalf of the community, we would also like to thank the thousands of clinical trial patients whose unwavering commitment made this progress possible.”