FDA Approves Aimovig for Migraine Prevention
Erenumab is the first CGRP antagonist to be approved by the FDA for migraine prevention in adults.
The U.S. Food and Drug Administration has approved erenumab (Aimovig™, Amgen and Novartis), a first-in-class calcitonin gene-related peptide (CGRP) antagonist, for the prevention of migraine in adults.
Erenumab consistently demonstrated an ability to reduce monthly migraine days in patients with episodic and chronic migraine in 3 major clinical trials, ARISE, STRIVE, and LIBERTY. The drug, which is indicated for once-monthly use, will be available to patients in both a 70 mg and 140 mg self-administered auto-injector within 1 week of the approval.
“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 New Hampshire, in a statement. “Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success. Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of 2% percent due to adverse events – and experienced sustained migraine prevention.”
The drug has been evaluated in more than 3000 patients, and its efficacy, tolerability, and safety continue to be examined in an ongoing 5-year open-label extension study. The most commonly reported adverse events through all trials have been injection site reactions and constipation.
Erenumab will cost $575 for a once-monthly dose of 70 mg or 140 mg, or $6900 annually. While out-of-pocket costs will vary based on patient insurance status, Amgen and Novartis have launched the Aimovig Ally program and Aimovig Copay Program to help reduce costs to as low as $5 per month for commercially-insured patients and help uninsured patients identify potential access resources.
Erenumab is the first of 3 anti-CGRP drugs currently under review to cross the FDA finish line. Teva's fremanezumab and Eli Lilly and Co.'s galcanezumab are both awaiting a decision, and Alder's eptinezumab NDA is expected later this year. Erenumab is currently under review by the European Medicines Agency, as well.
FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention [press release]. Thousand Oaks, CA: Amgen; May 17, 2018.