FDA approves Aimovig, injection for chronic migraines
Millions of people have severe migraines so frequently that they are “disabled and in despair,” reported Gina Kolata in the New York Times News Service. In fact, one in seven Americans suffers from migraines, harsh headaches that are frequently accompanied by nausea and visual auras, according to Leah Rosenbaum in Science News.
A new drug, approved by the Food & Drug Administration (FDA) in May will not be able to prevent all migraine attacks, but it can make them less severe and can reduce their frequency by 50 per cent or more. The first medicine designed to prevent migraines could preface what numerous experts think will be “a new era in treatment for people who suffer the most severe form of these headaches,” the New York Times article said.
Aimovig, which is offered by Amgen and Novartis, is a monthly injection with a device that is similar to an insulin pen. The drug will be available at $6,900 per year, and it is already available to patients. Aimovig blocks a protein fragment, CGRP, that triggers and perpetuates migraines. The new drug, generically called erenumab, is a monoclonal antibody treatment, resembling naturally produced antibodies that the body uses to bind to infectious pathogens. It works by targeting specific proteins and their receptors that contribute to disease. Aimovig targets the receptor for a protein called calcitonin gene-related peptide, or CGRP, that is elevated in people with a migraine attack. The protein is released from nerve endings throughout the body. When it attaches to the receptor, CGRP widens blood vessels to cause inflammation and pain. When Aimovig is used once a month with an EpiPen-like injector, it blocks the receptor for CGRP, thus diminishing pain.
Lilly, Teva and Alder have similar medicines in the final stages of study or awaiting FDA approval. Instead of targeting CGRP’s receptor, the other medications target the protein itself. They will be delivered by differing mechanisms.
According to Dr. Amaal Starling, a neurologist and migraine specialist at the Mayo Clinic in Phoenix, “The drugs will have a huge impact. This is really an amazing time for my patient population and for general neurologists treating patients with migraine.”
At the moment, Aimovig seems to have minimal side effects in clinical trials. Still, the drug will be monitored for long-term effects on pregnant women, people with cardiovascular conditions and others. Rosenbaum noted that CGRP can have positive effects on the body: it helps to relax arteries, including those around the heart, and leads to improved blood flow and a lower heart rate. Further studies may indicate whether the bodies of people who take Aimovig, a CGRP receptor blocker, can perform these essential functions in a cardiovascular emergency.
According to a recent editorial in the journal JAMA, Aimovig represents “progress, but not a panacea.” As Dr. Stewart J. Tepper, a professor of neurology at Dartmouth College, said of the new drugs, “For now, they look fantastic. They shake the ground under our feet. They will change the way we treat migraine.”