The US Food and Drug Administration (FDA) today approved the fully human monoclonal antibody erenumab for the prevention of migraine in adult patients.
Amgen will charge $6,900 a year for the drug—which will be marketed under the name Aimovig. The company estimates that 24 million people in the U.S. alone that can be helped with the drug.
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.
The Coalition for Headache and Migraine Patients—a patient advocacy group– was pleased the FDA approved the drug. CHAMP’s Executive Director Kevin Lenaburg issued the following quote.
“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. 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.”
Lily, Teva Pharmaceutical and Alder Pharmaceuticals are all working with CGRP products for the treatment of migraines. None are yet approved.
The Migraine Research Foundation says that 39-million people in the U.S. and one-billion world wide suffer from migraines and that it is the third most prevalent disease in the world.