The US Food and Drug Administration (FDA) today approved the fully human monoclonal antibody erenumab (Aimovig, Amgen and Novartis) for the prevention of migraine in adult patients.
The once-monthly self-injectable drug, which is a calcitonin-gene-related peptide (CGRP) antagonist, is the first in its class to receive FDA approval for this indication.
"Aimovig provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition," Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a press release.
The agency said it gave the nod because of strong results from several recent clinical trials.
As previously reported by Medscape Medical News, findings from the LIBERTY trial were presented at the American Academy of Neurology (AAN) 2018 annual meeting last month. The study, which included 246 patients with refractory episodic migraine, showed that a 50% or greater reduction in mean monthly migraine days (MMDs) was achieved by 30% of those treated subcutaneously once monthly with erenumab 140 mg vs 13.7% of those receiving matching placebo (the primary endpoint).
Efficacy and safety for the drug were also shown in patients with episodic and chronic migraine in the previous phase 3 STRIVE and ARISE trials.
At the AAN 2017 annual meeting, lead author of the STRIVE trial Peter Goadsby, MD, PhD, professor of neurology at the University of California, San Francisco, told Medscape Medical News that migraine "is the biggest cause of disability due to neurological problems" in the world today.
However, he noted that this new treatment is a migraine-specific preventative, which clinicians haven't had previously. "What isn't exciting about that?" asked Goadsby.
Race to Market
In addition to erenumab, three other anti-CGRP antibody treatments have been in a race to market. This includes fremanezumab (Teva Pharmaceuticals) and galcanezumab (Eli Lilly and Co), which are currently under review. The manufacturer of eptinezumab (Alder BioPharmaceuticals) is expecting to file for FDA approval by the end of 2018.
According to Amgen, erenumab has now been assessed in more than 3000 total patients across its trials, including an ongoing open-label extension study that is planned to last for 5 years.
"Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine," said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School, in a company press release. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy — with a discontinuation rate of 2% due to adverse events — and experienced sustained migraine prevention."
The FDA noted that the most common adverse effects reported by the trial participants were injection site reactions and constipation.
According to the company release, the US list price for erenumab will be $575 for a once-monthly 70- or 140-mg single-use prefilled autoinjector, or $6900 annually. Costs to patients will vary depending on insurance status, but the company notes that its programs may help reduce a patient’s out-of-pocket costs to as little as $5 per month for those who are eligible.
The drug is expected to be available to patients within 1 week.
The European Medicines Agency accepted a marketing authorization application for the CGRP receptor blocker in June 2017; the FDA accepted its new drug application 1 month later.
"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," Kevin Lenaburg, executive director of the Coalition for Headache And Migraine Patients (CHAMP), said in another release.
"Today we celebrate the tireless work of researchers...and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days," added Lenaburg.