Home Must See Revolutionary New Migraine-Preventing Drug Wins FDA Approval

Revolutionary New Migraine-Preventing Drug Wins FDA Approval

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Monthly anti-migraine injections have won US Food and Drug Administration approval, a month after the results of clinical trials were presented at the American Academy of Neurology’s annual meeting. Unfortunately, the cost could induce headaches in those without health insurance.

The throbbing pain, nausea, and light-sensitivity of migraines, recently revealed to be a by-product of cold adaptation, affect more than 10 percent of people of European background, with more than 1 percent suffering at least every three days. Although some sufferers respond to safe, easily available painkillers, untreatable migraines represent one of the major causes of disability in the developed world.

Aimovig, generically known as erenumab, prevents migraines starting, rather than tackling them after they have begun. It blocks the molecule that transmits the migraine pain signals, known as calcitonin gene-related peptide (CGRP). The action is so long-lasting, treatment can be offered in the form of monthly 70 or 140-milligram injections, rather than regular pills.

Erenumab’s manufacturer, Amgen, has announced that the cost of an injection will be $575 in the US, making the price of an annual dose $6,900. Erenumab is under consideration by the European Medicines Agency, and if approved the cost will depend on negotiations between Amgen and public health systems. The price will be the same for the smaller or larger dose, reflecting the fact that the manufacturing cost is tiny compared to the expense of identifying erenumab’s potential and having it pass clinical trials.

Amgen has a different take on the cost, arguing in a statement; “The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers, and employers, while also factoring in critical issues such as patient affordability, and fair and timely access.”

In addition to painkillers and triptans, which ease migraine effects when taken after one starts, preventative treatments for migraines already exist in the form of blood-vessel constrictors and Botox treatments. However, the side-effects of existing drugs are often as severe as the migraines themselves, while Botox is costly and its effectiveness mixed.

Side-effects of erenumab, as reported in clinical trials, were very low.

On the other hand, the drug is no cure-all. Thirty percent of those in trials reported a halving or better of their migraines, and a lucky few had the pain stop entirely, but most experienced more modest benefits. Moreover, since trial participants in the control group reported a substantial, although smaller, improvement, it appears part of the benefit comes from the placebo effect.

Given the tens of millions of people who suffer from migraines, the average reduction of one migraine a month, rising to 2.5 per month among chronic sufferers, could still make a major difference to global quality of life.

Read more: http://www.iflscience.com

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