First Monoclonal Antibody Blocking CGRP Approved for Treatment of Migraine
The Food and Drug Administration today approved erenumab-aooe (Aimovig; Novartis, East Hanover, NJ) for prevention of migraine in adults. Erenumab is a monoclonal antibody that blocks the calcitonin gene-related peptide (CGRP) receptor and is delivered at a dose of 70 mg in a prefilled autoinjector (SureClick; Amgen, Thousand Oaks California) used monthly. Some patients may benefit from a dose of 140 mg.
As reported previously in Practical Neurology, in an open-label extension trial 65% of patients with episodic migraine who received 70 mg of erenumab for 64 weeks had more than a 50% reduction in their frequency of monthly migraine days. In a phase 3 trial, erenumab reduced treated patients’ monthly headache days by 1.4 (70 mg dose) and 1.9 (140 mg dose) compared to placebo. Erenumab is the first CGRP-related and the first monoclonal antibody treatment for migraine to be approved by the FDA; 3 others are in phase 3 clinical trials.
The efficacy, tolerability and safety of Aimovig has been assessed in more than 3,000 patients, including LIBERTY and an ongoing open-label extension of up to five years in duration. In clinical studies of Aimovig, the most common adverse reactions were injection site reactions and constipation.
Amgen and Novartis have committed to support patients with migraine by helping appropriate patients affordable access. The US list price of each dose is $575 for a single-use prefilled autoinjector. As out-of-pocket costs will vary depending on each patient’s insurance status, Amgen and Novartis have initiated an Aimovig Copay Program that may reduce out-of-pocket costs for eligible patients with commercial insurance to as little as $5 per month. More information about the Aimovig Copay Program is available at www.aimovig.com.
“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., 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.”
"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 Stewart J. Tepper, MD, 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."