Amgen’s Aimovig Nabs FDA Approval for Migraine Prevention

After releasing stellar Phase III clinical trial results, Amgen has announced that their preventive treatment for migraine Aimovig (erenumab-aooe) has been approved by the US Food and Drug Administration (FDA). The biologic drug is designed to prevent migraine by targeting the calcitonin gene-related peptide receptor (CGRP-R), and is the first regulator-approved drug for this indication.

“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,” said 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.”

Aimovig is self-administered via Amgen’s SureClick autoinjectorat a dose of 70 mg or 140 mg once monthly. In Amgen’s Phase IIIb LIBERTY trial, patients with episodic migraine who had previously failed to respond to up to four other therapies were three times more likely to experience half as many migraine days per month when taking Aimovig.

“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.”

The migraine prevention drug was co-developed with Novartis, and both drugmakers are expected to be granted EMA approval for Aimovig in Europe in the next few months. The two companies have established the Aimovig Ally program to help migraine patients overcome affordable access issues to the medication, which is expected to be available to patients within the week.

“The FDA approval of Aimovig reflects the Novartis commitment to advancing neuroscience and marks an important moment in the fight against migraine,” said Fabrice Chouraqui, US President of Novartis Pharmaceuticals Corporation. “Migraine is a serious and misunderstood disease with significant gaps in the way it is both perceived and treated. In close partnership with Amgen, our goal in the US is to bring meaningful therapeutic options to patients, while also helping them to overcome the personal, professional and clinical barriers that have long been associated with this stigmatized disease.”

Amgen and Novartis have set the list price for Aimovig at $575 per month for the prefilled SureClick autoinjectors. At an annual cost of $6,900 before rebates and discounts, the price of Aimovig has fallen short of some analysts’ estimates which could mean more widespread payer coverage of the drug.

“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,” said 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.”

According to the FDA, over 10 percent of the world’s population is affected by migraines, which are three times more common in women. In contrast to the occasional headache, migraine sufferers experience intense pain which can be accompanied by nausea, vomiting as well as sensory sensitivities.